You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here. This article is not on good documentation practice (GDP) this article is not covering data integrity In this article, I am going to explain basic things on the documentation which are applicable anywhere. In this article, We will understand the following terminology which will be useful in the entire learning journey Basically, this article is published for conceptual clarity What is Documentation? What is the difference between Documents and records? Structure of Documentation Importance of The Documentation What is Documentation? The Documentation is a combination of Document, Record, Its generation, archival, and destruction (Lifecycle) What is the difference between Documents and records? Documents: Present Current Can be revised Explaining What to do Explaining How to do Instruction Records: Past Permanent Cannot be changed Explaining What have been done Explaining How it has been done Evidence Compare carefully point to point for better clarity Structure of Documentation The Documentation structure is explained by the Documentation pyramid. This pyramid of the documentation describes the operational flow of documented information in the organization and represents the levels for the types of documents that are usually used in a Quality Management System (QMS), from the planning of strategic stages to the daily work of performing activities and filling out forms. This method clearly illustrates that with each descending level of the pyramid, the amount of required documented information will increase. This kind of pyramid provides navigation for users throughout the various documentations in the organization. In other words, when an interested party (internal like a user or an employee or external like an auditor) needs to get familiarize with the documentation of the organization, they can use this structure for orientation. Level-1 Documentation Strategic Level These documentations are called Policy documents; In the first level of the documentation pyramid, we will find documentation of declarative statements by the organization that includes the key elements of the QMS, and that will set the strategic direction of the QMS. This documented information has a clear goal: to introduce and communicate the intentions, scope, and structure of the QMS in the organization. It includes elements such as QMS scope, quality policies, quality objectives or references to them, organizational structure, exclusions, the general process of the organization, etc. Example: Quality Policy, Quality Manual, Site Master File (SMF), Validation Master Plan (VMP) Level-2 Documentation Workflow and Core Processes Workflow describes the work process of an organizational unit (an organization or a part of the organization) where each step depends on the preceding step. It depicts the business activity with step processes, their resources, their sequences (progression), and interactions that transform inputs into outputs, for example, materials into goods or information into services. Workflow can appear as a diagram or as a description (text). Example: Master Formula Record, Organogram, Department manual Level-3 Documentation Procedures or Process Diagrams to Support Quality Activities On this level, you may include procedures or instructions that support quality activities that the standard describes and demands, The documentation which is required to maintain the Quality Management system shall include in this level Maintenance of documented information Control of nonconforming product Internal audit Corrective action Risk Management QMS SOP / Protocols Level-4 Documentation Quality Plan, SOPs, Specifications, Process Diagrams, Procedures, Work Instructions, and Forms This type of documented information, which belongs to the fourth level in our pyramid, has the goal of supporting operations of processes and directing and instructing personnel on how to perform activities. This type of documented information has the objectives of Supporting the workflow in the organization Defining the required information and data needed to perform activities and operate processes Describing the responsibilities and authorities of people and/or organizational functions regarding processes and activities Ensuring effective planning, operations, and control activities during the realization of the product Describing activities needed to support the workflow Describing the interrelations of processes or activities Describing methods for monitoring and measurement activities Describing the expected evidence and records Communicating information regarding processes and activities Assisting in training Reducing mistakes Level-5 Documentation Records Every activity is generating the records, results, evidence, or proofs, it is very important to maintain as per its lifecycle. The record shall be archive in such a way so it can be retrieved within the stipulated time. Example: Executed forms, Executed Batch records, Validation / Qualification Reports... Importance of The Documentation Remember, If you want to sale you are the product in any country, first of all, you have to clear the registration process --- This requires Documentation During Audit; the Auditor is auditing three following things; The Procedure (SOP) --- this is Document The practice which they observe during the audit, which must be matched with your SOP--- The SOP is Document The Auditor verifies evidence for the activity which is not performed in front of them--- this is records So you can understand the importance of documentation To update yourself; regularly visit our website: www.pharmaceuticalguideline.com and become a member (it's FREE) by clicking the Login button at the top right corner of the webpage, also subscribe to our newsletter, Like our website, follow us on Facebook (https://www.facebook.com/pharmaceuticalguideline) Instagram (https://www.instagram.com/pharmaceuticalguideline/) LinkedIn (https://www.linkedin.com/company/pharmaceuticalguideline) Twitter (https://twitter.com/pharma_guidance) Telegram, Download Telegram App on your Mobile and use @pharmaceuticalguideline for search.

This Article is important for Fresher, Experienced employee and Employer (Entrepreneur) In this article, we will understand the Basic Functions of Key departments of the Pharmaceutical Organization. The requirement of the Department in Industry: The Key Departments in the pharmaceutical Industry: Basic Functions of key departments; I have observed during the interview of the fresher candidate; they have no proper clarity regarding the Basic Functions of a particular department when I ask the question “Why you have applied in The XYZ Department?”, “Why you have chosen the XYZ Department?” or “What you know about XYZ Department?” 95% of Candidates replying “As there is a vacancy...” I personally feel that there should be no gap between the Education syllabus and the Industrial requirement. The Education system is providing candidates to Industry (for understanding; we can consider Candidate as a Product and Industry as a Customer) as a basic principle of Marketing, the Product should meet Customer Requirement Specification... To clarify the departmental basic functions of the industry to the Students/Candidates is a moral responsibility of the Academic person and experienced person of the Industry. I am utilizing this platform for the same, Hopping it will helpful to many Students/Candidates. The requirement of the Department in Industry: Based on the Business model of the Company; the workflow should be established. We will understand by taking the example of a small company who have limited staff (employee); This company has to distribute the work to the employee in such a way so employees can accomplish the work smoothly. The company should not create so many departments at this stage, but as the company is growing they have to reorganize the workflow and departmental role & responsibilities. The workflow and people (employee) should be organized for efficient utilization of manpower and it should be reviewed periodically; that is the real meaning of the word “Organization” The Key Departments in the pharmaceutical Industry: Quality Assurance (QA) Quality Control (QC) Microbiology (Micro) Research / Formulation and Development (R&D or F&D) Analytical Method Development Laboratory (ADL) Warehouse (Stores) Production and Packing Engineering (Utility) Human Resources (HR) and Admin Environmental Health and Safety (EHS) Information Technology (IT) Purchase Accounting Marketing / Business Development Supply Chain Management Basic Functions of the Key Departments: The functions may vary based on organizational requirements; however, the following basic functions are provided for understanding. Note: Here I am not providing the definition of the department, the text is content basic functions as per industrial practice. The detailed information of the functions will be provided in subsequent Articles and/or Short Notes. Quality Assurance (QA): This department is an important department of the organization as this department is a requirement of the regulation. Quality assurance is providing guidance and inculcating the people for the development of quality culture in the organization The few activities are as follows; Vendor Qualification Service agency Qualification Equipment Qualification Analyst Qualification Instrument Calibration Process Validation Cleaning Validation Quality Management System Change control Deviation Control Approval of Analytical Method Validation Market Complaint Investigation Risk Management Corrective Action and Preventive Action Out of specification investigation and approval Standard operating procedure development and approval Stage wise in-process testing Approval of method of analysis for quality control laboratories Training of the employee as per good manufacturing practice requirement Document and data control Internal Audit Batch release for the market Product stability All the activity where product quality is directly or indirectly involved Quality Control (QC): QC function is related to analysis as per validated and approved Method and the result shall be compared with the pre-defined approved specification. The few activities are as follows; Maintain laboratory as per Good Laboratory Practice (GLP) Analytical Method Validation Preparation of Specification and Method of Analysis Instrument Calibration Analysis of Raw Material, Packaging Material, Inprocess sample, Finished Goods sample, Stability Sample, Market Complaint Sample, Other samples, etc. Control Sample Storage Stability Study Out of Specification Investigation Preparation of Certificate of Analysis (CoA) Microbiology (Micro): Microbiology department function is also related to Microbiological analysis/testing as per validated and approved Method and the result shall be compared with the pre-defined approved specification. The Functions are common between QC and Micro like… Maintain laboratory as per Good Laboratory Practice (GLP) Analytical Method Validation Preparation of Specification and Method of Analysis Instrument Calibration Analysis of Raw Material, Packaging Material, Inprocess sample, Finished Goods sample, Stability Sample, Market Complaint Sample, Other samples, etc. Out of Specification Investigation This department is considered as a sub-department of QC in many organizations. Research / Formulation and Development (R&D or F&D): The R&D department is involved in research work; search for a new molecule, synthesis and modification of known molecules or some methods to increase productivity by adopting different techniques. This department is required Highly Knowledgeable candidate, many organizations have their R&D Department. The F&D department is working on the development of product formulation. Product development is an essential and first part of the product life cycle. This department has to carry out the development of a stable product and transfer it to the production department for routine commercial manufacturing Analytical Method Development Laboratory (ADL): An analytical method is required to analyze any material or product. This department is working on the development of the analytical method which is suitable for the instrument available in the laboratory, The analytical method should be developed considering the parameter of method validation Typical validation parameters recommended by FDA, USP, and ICH are as follows: Specificity Linearity and Range Precision Method precision (Repeatability) Intermediate precision (Ruggedness) Accuracy Solution stability Limit of Detection (LOD) Limit of Quantification (LOQ) Robustness Warehouse (Stores): It includes storage of Raw material, Packaging material, ancillary material, intermediate material engineering material, finished goods The basic functions are as follows; Maintain Good Storage Practice Receipt and verification of the material Segregation of the material at various stages like Quarantine, Under test, Approved Reject Maintain the recommended storage condition Reconciliation of the material and stock maintenance Dispensing of the material Most of the audit starts from Warehouse; as this department is the starting point as per material flow. Production and Packing: This department is the center of business, other departments are supporting or service departments The basic functions are as follows; To maintain Good Manufacturing Practices Manufacturing of the product Manpower Handling Maintain Quality of the product at the various production stages Final Product packing Preparation of Batch manufacturing and Packing Record Maintain other records (e.g. Logbook) as per GMP requirement Engineering (Utility): This department provides support to increase productivity, Decrease cost by utilizing engineering knowledge. The Basic Functions of this department are as follows; Follow the Good Engineering Practice Maintenance of Building / Facility Preventive Maintenance of Equipment/Instrument Breakdown Maintenance The constant supply of required utility Water System Handling HVAC System Handling including AHU, Cooling Tower, Chiller, etc. Manpower Handling Human Resources (HR) and Admin: This department play important role in the organization, as HR is dealing with employee (human). You can purchase machinery by paying money, but you have to retain humans with you with emotion; you cannot purchase by money for a longer time. The basic functions of this department are as follows; Maintain relation with personnel as a representative of management To follow Act and Rule as per law of land (factory Act, Labour Law, etc.) Recruitment of Manpower To aware employee about Personnel Hygiene Medical checkup of the employee Maintain a statutory record of the employee like Attendance, Leave, PF, ESI, etc. Environmental Health and Safety (EHS): This department is taking care of ... Corporate social responsibility (CSR), pertains to people and organizations behaving and conducting business ethically and with sensitivity towards social, cultural, economic, and environmental issues Employee Safety at Workplace The basic functions of this department are as follows Employee safety at the workplace Provided training related to fire safety and other safety at the workplace Provide Fire fighting training Provide first aid training Provide training on the emergency evacuation plan to employees and visitors Conduct mock drill Environmental safety Information Technology (IT): Now a days electronic data is ecencial part of the business. This department is taking care of following things as per Good Manufacturing Practice (GMP) requirement, Maintenance of IT infrastructure Data buckup Data security Purchase: This department is related to commercial operation however, Some Good Manufacturing Practice (GMP) requirement should be taken care by this department as follows, Vendor identification Procurement of the required material from the approved vendor list Ensure material availability as per production planning Communicate and coordinate with vendor for Vendor Audit and at the time of complaint regarding the material or the product which is manufactured using the material supplied by the vendor. Accounting: This department is related to commercial operation. The basic functions are as follows, To maintain the commercial transactions Maintain accounting of the same Costing of the batch Supply Chain Management: This department is responsible for maintain recommended storage condition during transit and storage up to distribution. the storage condition is directly impact to the Product Quality. In pharmaceutical it is important to maintain track record of the quantity distributed, it is required whenever product needs to be recalled from the market in any unfavorable condition. The basic functions of the department are as follows, Follow the good distribution practice as per regulatory requirement Arrange transportation from factory to customer destination Tracking of the product wise and customer wise distribution provide the data to the quality assurance department as and when required. Coordinate with customer and Quality Assurance for Mock Recall of actual Product Recall I have tried to cover Key departments information in this article, however, the detailed information will be provided in subsequent Article and Short Note. To update yourself; regular visit our website: www.pharmaceuticalguideline.com and become a member (its FREE) by clicking the Login button at the top right corner of the webpage, also subscribe for our newsletter. A3

In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance Challenges What is not Quality Policy What is Quality Policy How to craft the Quality Policy · Importance Imagine that you are an owner of the Pharmaceutical Organisation; What should be your Policy towards patient safety? How your product should provide Quality and Safety assurance to patients… All GMP and ISO 9001guidelines are expecting from Top management “Top Management is responsible for establishing, reviewing, and maintaining the quality policy and quality objectives.” Do you know which document should be the first document of the Pharmaceutical Organisation? The Answer is QUALITY POLICY… By this Document, the regulatory is accessing the thought process of top management. · Challenges Every Owner of the Pharmaceutical Organisation facing challenges for QUALITY POLICY… How to develop a document (QUALITY POLICY) which delivers correct thoughts to the entire origination, regulatory agency, and customer. How to implement the Quality Policy in the Organisation In many organizations, the Quality Policy is just printed on paper for documentation purposes, it may be framed and hanged, but nobody is reading it… Quality Policy is the document which is influenced the culture of the organization if it is implemented systematically. We have to understand “The traditional procedures and controls,” should not barriers to innovation. “The way that we approached quality in the past is not the way that we should be approaching quality today,” we have to set up an updated policy that emphasized ongoing quality improvements and organizational agility. The SOPs, ensuring that all the documents explained the “why” behind procedures, linking the individual’s role to the organizational Vision & mission. We should change our thinking about quality by simplifying the policy and systems, along with adopting new technologies for collaboration. Many pharma industry leaders are discovering that the quality policy is a lot more than necessary legal fine print. An effective quality policy is a cultural framework that shows the entire origination, regulatory agency, and customer the standard for consistently delivering the best possible pharmaceutical product or service. · What is not Quality Policy The quality policy is not the same as the quality manual, quality management system (QMS), or standard operating procedures (SOPs). It is not prescriptive, and it does not describe anyone how to do anything. · What is Quality Policy The policy is a declaration of “WHY” your company is committed to a quality-driven culture. The quality policy is a baseline for building an effective QMS and SOPs. it is the non-optional foundation for pharmaceutical QMS. The quality policy is upheld by management support and the right systems, A policy which prescribes quality as a value-add activity is put into action with an agile · How to craft the Quality Policy Following Points should be considered while developing the Quality Policy A pharmaceutical quality policy is a statement/principle of action that describes an organization’s commitment towards quality operations and products. it should cover; 1. The intention of the top management towards Quality 2. The intention of the top management towards Regulatory requirement 3. Commitment to Continual Improvement 4. Code of Ethics 5. Code of Conduct 1. The intention of the top management towards Quality This is a very important ingredient for crafting a quality policy. ISO 9001:2015 requires the quality policy is appropriate for an organization's strategic and operational directions. It needs to describe briefly who your company is, whom you serve, and why quality matters to the organization. this should be the first section of a policy. 2. The intention of the top management towards Regulatory requirement The quality policy must address the organization’s intent to fully comply with regulatory requirements. It doesn’t need to describe how you will uphold regulatory frameworks, however, It also does not need to describe which regulations you meet. The compliance intention section should be kept short and avoid more details. The quality manual and QMS put regulatory compliance into action, not the policy. 3. Commitment to Continual Improvement Continual improvement is the goal of the pharmaceutical quality system (PQS), according to ISO 9001 and ICH Q10 standards. The quality policy should address your organization’s commitment to continually getting better. It does not need to describe the mechanisms for continuous improvements, such as CAPA or management review. 4. Code of Ethics Ethical practices are an important part to maintain quality, patient safety is a prime responsibility of the organization. Hence; here how the code of ethics is impacting or controlling the quality of the product or service. However, a separate code of ethics should be prepared 5. Code of Conduct Here; we have to mention how the code of conduct is impacting or controlling the quality of the product or service. The entire code of conduct is different document quality policy shouldn’t be a substitute for comprehensive conduct standards for employees. The Quality Policy should be; short and sweet, avoid so many paragraphs, easy to understand and incorporate it into the daily work. The quality policy should reflect the “WHY” of the organization, The QMS documents should explain “HOW” it can be achieved.

Pharmaceutical Industry contributes to improving the health and wellbeing of society. While there are different types of the pharmaceutical business, they all help in discovering, developing, and manufacturing medications. Different types of pharmaceutical companies work in various ways to create unique treatments and medicines. However, pharmaceutical industries inevitably affect almost the entire global population in some way. Different types of pharma business and types of pharmaceutical industries. Finished Formulation / Medical Device Oncological Formulations Parenteral Formulations Oral drugs Formulations Topical Medicines Medical Device Raw Material Manufacturer for Finished Formulation Active Pharmaceutical Ingredient (API) Excipients Intermediate product for API manufacturing Chemicals for Intermediate and API manufacturing Other Service providers Pharmaceutical Equipment / Instrument manufacturing Qualification / Validation / Calibration service providers Analytical Laboratories Research and development laboratories Utility Suppliers Packaging Material Manufacturer Supporting service providers The Pharmaceutical industries are providing jobs to many peoples at a good salary, As we all aware; in Covide19 (#Covid19, #Corona) situation; the people of this Industry have provided the best support to society. This industry was run 24x7 in this pandemic condition. We are thankful to the employee and employers who have continued their duty as warriors. To obtain a job or building a career in Pharmaceutical Industries; there are some basic requirements, Appropriate Educational qualification Good Academic record Good Resume / Curriculum Vitae to represent yourself on document Preparation for Interview After Getting a Job; it is very important to learn industrial practice and requirements in the initial 3 years. Academic knowledge is the base, but you must acquire knowledge about the industrial practice and Develop skills required by the industry. Our Dynamic Pharma Team is providing a step by step learning topic on this website. You will find Short Note, Article, SOP, Protocol, Video, Audio, Discussion, and Webinar. For Learning of pharmaceutical topic, regularly visit our website, subscribe to our newsletter by providing your Email or you can become a member by log in to our website A1

General Notices (Ph. Eur. monograph 0499) Granules comply with the requirements of the European Pharmacopoeia. These requirements are reproduced below. Ph Eur Requirements for granules to be used for the preparation of oral solutions or suspensions are given in the monograph on Liquid preparations for oral use (0672). Where justified and authorised, the requirements of this monograph do not apply to granules for veterinary use. DEFINITION Granules are preparations consisting of solid, dry aggregates of powder particles sufficiently resistant to withstand handling. They are intended for oral administration. Some are swallowed as such, some are chewed and some are dissolved or dispersed in water or another suitable liquid before being administered. Granules contain one or more active substances with or without excipients and, if necessary, colouring matter authorised by the competent authority and flavouring substances. Granules are presented as single-dose or multidose preparations. Each dose of a multidose preparation is administered by means of a device suitable for measuring the quantity prescribed. For single-dose granules, each dose is enclosed in an individual container, for example a sachet or a vial. Where applicable, containers for granules comply with the requirements of Materials used for the manufacture of containers (3.1 and subsections) and Containers (3.2 and subsections). Several categories of granules may be distinguished: — effervescent granules; — coated granules; — gastro-resistant granules; — modified-release granules. PRODUCTION In the manufacture, packaging, storage and distribution of granules, suitable measures are taken to ensure their microbial quality; recommendations on this aspect are provided in the text on 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use. TESTS Uniformity of dosage units Single-dose granules comply with the test for uniformity of dosage units (2.9.40) or, where justified and authorised, with the tests for uniformity of content and/or uniformity of mass shown below. Herbal drugs and herbal drug preparations present in the dosage form are not subject to the provisions of this paragraph. Uniformity of content (2.9.6) Unless otherwise prescribed or justified and authorised, single-dose granules with a content of active substance less than 2 mg or less than 2 percent of the total mass comply with test B for uniformity of content of single-dose preparations. If the preparation has more than one active substance, the requirement applies only to those substances which correspond to the above conditions. Uniformity of mass (2.9.5) Single-dose granules except for coated granules comply with the test for uniformity of mass of single-dose preparations. If the test for uniformity of content is prescribed for all the active substances, the test for uniformity of mass is not required. Uniformity of mass of delivered doses from multidose containers (2.9.27) Granules supplied in multidose containers comply with the test. STORAGE If the preparation contains volatile ingredients or the contents have to be protected, store in an airtight container. EFFERVESCENT GRANULES Requirements for granules to be used for the preparation of oral solutions or suspensions are given in the monograph on Liquid preparations for oral use (0672). Where justified and authorised, the requirements of this monograph do not apply to granules for veterinary use. DEFINITION Effervescent granules are uncoated granules generally containing acid substances and carbonates or hydrogen carbonates which react rapidly in the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water before administration. TESTS Disintegration Place one dose of the effervescent granules in a beaker containing 200 mL of water R at 15-25 °C; numerous bubbles of gas are evolved. When the evolution of gas around the individual grains ceases, the granules have disintegrated, being either dissolved or dispersed in the water. Repeat the operation on 5 other doses. The preparation complies with the test if each of the 6 doses used disintegrates within 5 min. STORAGE In an airtight container. COATED GRANULES Requirements for granules to be used for the preparation of oral solutions or suspensions are given in the monograph on Liquid preparations for oral use (0672). Where justified and authorised, the requirements of this monograph do not apply to granules for veterinary use. DEFINITION Coated granules are usually multidose preparations and consist of granules coated with one or more layers of mixtures of various excipients. PRODUCTION The substances used as coatings are usually applied as a solution or suspension in conditions in which evaporation of the vehicle occurs. TESTS Dissolution A suitable test may be carried out to demonstrate the appropriate release of the active substance(s), for example one of the tests described in Dissolution test for solid dosage forms (2.9.3). MODIFIED-RELEASE GRANULES Requirements for granules to be used for the preparation of oral solutions or suspensions are given in the monograph on Liquid preparations for oral use (0672). Where justified and authorised, the requirements of this monograph do not apply to granules for veterinary use. DEFINITION Modified-release granules are coated or uncoated granules which contain special excipients or which are prepared by special procedures, or both, designed to modify the rate, the place or the time at which the active substance or substances are released. Modified-release granules include prolonged-release granules and delayed-release granules. PRODUCTION A suitable test is carried out to demonstrate the appropriate release of the active substance(s). TESTS Dissolution Carry out a suitable test to demonstrate the appropriate release of the active substance(s), for example the test described in Dissolution test for solid dosage forms (2.9.3). GASTRO-RESISTANT GRANULES Requirements for granules to be used for the preparation of oral solutions or suspensions are given in the monograph on Liquid preparations for oral use (0672). Where justified and authorised, the requirements of this monograph do not apply to granules for veterinary use. DEFINITION Gastro-resistant granules are delayed-release granules that are intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. These properties are achieved by covering the granules with a gastro-resistant material (enteric-coated granules) or by other suitable means PRODUCTION A suitable test is carried out to demonstrate the appropriate release of the active substance(s). TESTS Dissolution Carry out a suitable test to demonstrate the appropriate release of the active substance(s), for example the test described in Dissolution test for solid dosage forms (2.9.3). Ph Eur

News & Updates PIC/S [PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME] has revised guideline No. PE 009-16 [GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS] on 1 February 2022. Key Revision: Revision of Annex 13 Annex 13 (Manufacture of investigational medicinal products) New Annex added Annex 16 (Authorised person and batch release) Click Here to Download the Guideline Our Dynamic Pharma Team is providing a step-by-step learning topic on this website. You will find Short Note, Article, SOP, Protocol, Video, Audio, Discussion, and Webinar. For Learning about pharmaceutical topics, regularly visit our website, subscribe to our newsletter by providing your Email or you can become a member by login to our website. https://www.pharmaceuticalguideline.com/

Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the "standard" approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done and are kept current by review and approved revision on a predetermined schedule (usually annual), or when planned changes are made to the procedure or equipment and reagents used in the procedure. The original of a current version of an SOPs is maintained in a central file, and copies are distributed to the locations where the procedure is performed. The procedure for describing the writing, revising and approving of SOPs and the control of the distribution of SOPs is one of the important quality assurance procedures. The term “change control” has recently been introduced to the vocabulary of pharmaceutical manufacturing and control. Although this is primarily a term for validation procedures, it may also apply to the control of the review and revision of SOPs for routine procedures. Any SOP describing the distribution and control of documents must clearly indicate the mechanisms by which SOPs can be modified or changed: from assessment and rationale for the need for a change to the evaluation of other SOPs that might be changed as a result, to the final approval of changes and the implementation of the changed procedure. SOPs are used as a reference by the persons responsible for the performance and are also used for training new operators in the performance of the procedure. Quality assurance procedures should be in place to ensure that SOPs are enforced and properly used. SOPs follow a scientific format and are written with the view that they will be used by persons trained in the procedure. They should be specific instructions for each step in sequential order including the preparatory work which must be done before starting the main procedure, as well as instructions for recording and reporting the results. There is little need for excess text on theory and background - what is required is clear concise instructions for carrying out a procedure which has been approved. Usually, the initial draft of an SOP is written by the person performing the procedure or by someone who knows the procedure well and must be written including the details and the time course of the tasks. Supervisors review the SOPs for completeness and content and QC or QA staff approve for regulatory compliance. When appropriate, a formal data sheet or data record form is prepared for an SOP. This form is a parallel summary document with checklists, checkboxes, and blanks for all data to be recorded during the performance of the procedure. It also has spaces for signatures of the operator and other technicians who verify and countersign certain critical operations during the procedure. Finally, there is the space for the signature of the department supervisor who reviewed the completed data record form. Such blanks and checklists ensure that the required data are collected, that nothing is overlooked and also provide the evidence that the procedure was performed according to the SOP. The datasheets also provide instructions for recording deviations to the procedure, for calculations or reporting requirements, for comparison of results with predetermined specifications, and the criteria for repeating procedures in cases where unacceptable results were obtained.

1. Purpose To define the procedure for calibration of the Conductivity meter. 2. Scope This guideline is applicable for the calibration of the Conductivity meter in the Quality control department. 3. References & Attachments 3.1 References 3.1.1 Inhouse 3.2 Attachments 3.2.1 None 4. Responsibilities 4.1 Analyst 4.1.1 To operate the instrument as per SOP (Standard operating procedure). 4.1.2 Documentation related to Operation, Calibration and maintenance in the template/ logbook 4.2 Head Quality control or designee 4.2.1 To provide training to the concerned before implementation of SOP 4.2.2 To ensure the Operation and Calibration of the instrument as per SOP 4.2.3 To ensure proper documentation as per SOP. 4.3 Quality Head 4.3.1 To ensure the guideline is implemented at the location. 4.3.2 To review and approve SOP. 5. Definition of terms 5.1 Conductivity: It is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present. The unit of measurement of conductivity is Siemen (S). 6. Procedure 6.1 Categories of calibration and frequency of calibration 6.1.1 Meter calibration using resistors (Recommended Frequency Six Monthly ± 15 days) 6.1.2 The temperature sensor shall be calibrated. (Recommended Frequency Yearly ± 1 Month) 6.1.3 Recalibration shall be performed after major maintenance/breakdown of the instrument. If the maintenance is done for the temperature sensor then calibration of the sensor shall also be performed. 6.2 Check and Precautions 6.2.1 Check and ensure that no air bubble is trapped in the electrode while measuring conductivity. 6.2.2 Avoid contact of electrodes with solid surfaces. 6.2.3 Rinse the electrode with test solution before measurement. 6.2.4 Check the electrode for any surface solid deposits. 6.3 Calibration Procedures 6.3.1 Meter calibration using resistors (Frequency Six Monthly ± 15 days) 6.3.1.1 Meter calibration shall be performed using NIST or equivalent to local national authority traceable resistors which must be accurate to ± 0.1% of the stated value. 6.3.1.2 Alternatively, meter calibration may be performed using an accurate adjustable resistance device, such as Wheatstone Bridge, to give predicted instrument response. 6.3.1.3 The instrument must have a minimum resolution of 0.1 µS/cm. 6.3.1.4 The meter calibration shall be performed for each sensor. 6.3.2 The temperature sensor shall be calibrated Yearly ± 1 month with an accuracy of ± 0.5°C. Note: If in conductivity meter, digital temperature display is not available and the thermometer is used shall be graduated at not more than 0.5° C intervals. It shall be calibrated yearly once with 0.5° C accuracy. 7. Records Calibration Certificate

VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process. In addition, all work involved should be carried out in a structured way according to formally authorized standardized working and administrative procedures. In addition, validation is characterized by: Multidisciplinary approach: A specific characteristic of validation work is that it requires the collaboration of experts of various disciplines such as pharmacists, technologists, metrologists, chemical analysts, microbiologists, engineers, and experts on Q.A. validation, etc... Time constraints: Generally validation work is submitted to rigorous time schedules. These studies are always the last stage prior to taking new processes, facilities into routine operation. Costs: Validation studies are costly as they require the time of highly specialized personnel and expensive technology. 1.2. The above factors require a well-organized and structured approach that should be adequately described in a Validation Master Plan (VMP). 2. Purpose 2.1. The VMP should present an overview of the entire validation operation, its organizational structure, its content and planning. The core of the VMP being the list/inventory of the items to be validated and the planning schedule. 2.1.1. A VMP helps management: to know what the validation program involves with respect to time, people and money, and to understand the necessity for the program; 2.1.2. A VMP helps all members of the validation team: to know their tasks and responsibilities. 2.1.3. A VMP helps GMP inspectors: to understand the firm's approach to validation and the set up an organization of all validation activities. 3. Definition A Validation Master Plan is a document that summarises the firm's overall philosophy, intentions and approach to be used for establishing performance adequacy. 4. Scope 4.1. All validation activities relating to critical technical operations, relevant to the product and process controls within a firm should be included in a VMP. This includes the qualification of critical manufacturing and control equipment. 4.2. It should comprise all Prospective, Concurrent, Retrospective Validations as well as Revalidations. 4.3. In case of large projects like the construction of a new facility, often the best approach is to create a separate VMP. (In such situations the VMP should be part of the total project management.) 5. Format and Content 5.1. The VMP should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but refer to existing documents such as Policy Documents, SOP's and Validation Protocols/Reports. The VMP should be agreed by management. 5.2. A VMP should contain data on the following subjects / proposed chapters. 5.2.1. Introduction Firm's validation policy, general description of the scope of those operations covered by the VMP, location and schedule (including priorities). 5.2.2. Organisational Structure of All Validation Activities Personnel responsibility for the VMP, protocols of individual validation projects, validation work, report and document preparation and control, approval / authorization of validation protocols and reports in all stages of validation processes, tracking system for reference and review, training needs in support of validation. 5.2.3. Plant / Process / Product Description Provides a cross-reference to other documents. A rationale for the inclusion or exclusion of validations, for the validation approach and the extent of validation should be included. Note: A common principle in validation studies is to challenge processes, systems etc. The rationale behind any challenge and or “worst case” situation should be explained. Consideration can be given to the grouping of products / processes for the purpose of validating "worst case" situations. Where "worst case" situations cannot be simulated, the rationale for the groupings made should be defined. 5.2.4. Specific Process Considerations Under this heading specific characteristics/requirements of the plant/process etc. that are critical for yielding a quality product and need extra attention may be briefly outlined here. 5.2.5. List of Products / Processes / Systems to be Validated All validation activities comprised in the VMP should be summarised and compiled in a matrix format. Such matrix should provide an overview and contain: all items covered by the VMP that are subject to validation describing the extent of validation required [i.e. IQ, OQ and/or PQ]. It should include validation of analytical techniques which are to be used in determining the validation status of other processes or systems, the validation approach, i.e. Prospective, Retrospective or Concurrent, the Revalidation activities, actual status and future planning. 5.2.6. Key Acceptance Criteria General statement on key acceptance criteria for the items listed under (5.2.5) above. 5.2.7. Documentation Format The format to be used for protocols and reports should be described or referred to. 5.2.8. Required SOP's List of relevant SOP’s should be presented. 5.2.9. Planning & Scheduling An estimate of staffing (including training needs), equipment and other specific requirements to complete the validation effort should be described in the VMP. A time plan of the project with detailed planning of subprojects. This time plan could be included in the above mentioned matrix (5.2.5). A VMP requires regular updating. 5.2.10. Change Control A statement of the company's commitment to controlling critical changes to materials, facilities, equipment or processes (including analytical techniques), should be included.

The New Guidance Document is Issued by USFDA Guidance for Industry: Policy Regarding N-acetyl-L-cysteine Docket Number:FDA-2022-D-0490 Issued by: Center for Food Safety and Applied Nutrition The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of our intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled as dietary supplements. As described below, the enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. Download The Guidance

Update on New Guideline; by USFDA Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). U.S. Department of Health and Human Services Food and Drug Administration Office of Combination Products (OCP) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) July 2022 Labeling

How to calculate the requirement of commercially available Concentrated Hydrochloric Acid to prepare 0.1N or 0.1M HCl Solution? I am asking this question to many fresher candidates in interview; to evaluate their understanding of Chemistry, Maths, Convincing power etc. To calculate the required quantity of commercially available Concentrated Hydrochloric Acid to prepare 0.1N or 0.1M HCl solution following steps are to be understood, Concentration of collmericially available concentrated Hydrochloric Acid (HCl) = 32% v/v to 37% v/v (Why?) Let us consider 35% v/v (for example). Let us take an example; we want to prepare 500 ml of 0.1N or 0.1M HCl. Step 1 Calculate the Mass of HCl in 1000 ml 35% v/v Concentrated Hydrochloric Acid (HCl): 35% v/v Concentrated Hydrochloric Acid (HCl) = 36 ml HCl in 100 ml Water So, 360 ml HCl in 1000 ml Water The Density of HCl = 1.1789 g/ml Thus; Mass of HCl in 1000 ml water = 360 ml (HCl) x 1.1789 g/ml Density of HCl = 424.404 g Step 2 Calculate Molecular Weight of HCl: Molecular Weight of HCl = 1.0078 g/mole (H) + 35.453 g/mole (Cl) = 36.4608 g/mole Step 3 Calculate Molarity of 35% v/v Concentrated Hydrochloric Acid (HCl) Moles of HCl in 1000 ml water = Mass of HCl in 1000 ml water / Molecular Weight of HCl = 424.404 g / 36.4608 g/mole = 11.6400 Moles Hence, Molarity of 35% v/v Concentrated Hydrochloric Acid (HCl) = 11.64 M Step 4 Calculate The requirement of commercially available Concentrated Hydrochloric Acid to prepare 0.1N or 0.1M HCl Solution: Now, We will use the Dilution equation i.e. M1 x V1 = M2 x V2 M1 = 11.64 M [Molarity of 35% v/v Concentrated Hydrochloric Acid (HCl)] V1= We have to find out M2= 0.1 M [The concentration of HCl which we want to prepare] V2= 500 ml [The Volume of HCl which we want to prepare] So; V1 = M2 x V2 / M1 =0.1 M x 500 ml / 11.64 M = 4.2955 ml (Approximately 4.3 ml) The answer is The requirement of commercially available Concentrated Hydrochloric Acid to prepare 0.1N or 0.1M HCl Solution is 4.30 ml Note: The Acidity of HCl is one hence, the Normality (N) and Molarity (M) both are same.