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First Read Photostability Testing of New Drug Substances and Products First Read Photostability Testing of New Drug Substances Photostability Testing of New Drug Products: Normally, the studies on drug products should be carried out in a sequential manner starting with testing the fully exposed product then progressing as necessary to the product in the immediate pack and then in the marketing pack. Testing should progress until the results demonstrate that the drug product is adequately protected from exposure to light. The drug product should be exposed to the light conditions described under the Procedure , Normally, only one batch of drug product is tested during the development phase, and then the photostability characteristics should be confirmed on a single batch if the product is clearly photostable or photolabile. If the results of the confirmatory study are equivocal, testing of up to two additional batches should be conducted. For some products where it has been demonstrated that the immediate pack is completely impenetrable to light, such as aluminium tubes or cans, testing should normally only be conducted on directly exposed drug product. It may be appropriate to test certain products such as infusion liquids, dermal creams, etc., to support their photostability in-use. The extent of this testing should depend on and relate to the directions for use, and is left to the applicant’s discretion. The analytical procedures used should be suitably validated. Presentation of Samples Care should be taken to ensure that the physical characteristics of the samples under test are taken into account and efforts, such as cooling and/or placing the samples in sealed containers, should be made to ensure that the effects of the changes in physical states are minimized, such as sublimation, evaporation, or melting. All such precautions should be chosen to provide a minimal interference with the irradiation of samples under test. Possible interactions between the samples and any material used for containers or for general protection of the sample should also be considered and eliminated wherever not relevant to the test being carried out. Where practicable when testing samples of the drug product outside of the primary pack, these should be presented in a way similar to the conditions mentioned for the drug substance. The samples should be positioned to provide maximum area of exposure to the light source. For example, tablets, capsules, etc., should be spread in a single layer. If direct exposure is not practical (e.g., due to oxidation of a product), the sample should be placed in a suitable protective inert transparent container (e.g., quartz). If testing of the drug product in the immediate container or as marketed is needed, the samples should be placed horizontally or transversely with respect to the light source, whichever provides for the most uniform exposure of the samples. Some adjustment of testing conditions may have to be made when testing large volume containers (e.g., dispensing packs). Analysis of Samples At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity or color of solution, dissolution/disintegration for dosage forms such as capsules, etc.) and for assay and degradants by a method suitably validated for products likely to arise from photochemical degradation processes. When powder samples are involved, sampling should ensure that a representative portion is used in individual tests. For solid oral dosage form products, testing should be conducted on an appropriately sized composite of, for example, 20 tablets or capsules. Similar sampling considerations, such as homogenization or solubilization of the entire sample, apply to other materials that may not be homogeneous after exposure (e.g., creams, ointments, suspensions, etc.). The analysis of the exposed sample should be performed concomitantly with that of any protected samples used as dark controls if these are used in the test. Judgment of Results Depending on the extent of change special labeling or packaging may be needed to mitigate exposure to light. When evaluating the results of photostability studies to determine whether change due to exposure to light is acceptable, it is important to consider the results obtained from other formal stability studies in order to assure that the product will be within proposed specifications during the shelf life (see the relevant ICH Stability and Impurity Guidelines).

First Read Photostability Testing of New Drug Substances and Products PHOTOSTABILITY OF DRUG SUBSTANCE: For drug substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing. The purpose of forced degradation testing studies is to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation. This testing may involve the drug substance alone and/or in simple solutions/suspensions to validate the analytical procedures. In these studies, the samples should be in chemically inert and transparent containers. In these forced degradation studies, a variety of exposure conditions may be used, depending on the photosensitivity of the drug substance involved and the intensity of the light sources used. For development and validation purposes it is appropriate to limit exposure and end the studies if extensive decomposition occurs. For photostable materials, studies may be terminated after an appropriate exposure level has been used. The design of these experiments is left to the applicant’s discretion although the exposure levels used should be justified. Under forcing conditions, decomposition products may be observed that are unlikely to be formed under the conditions used for confirmatory studies. This information may be useful in developing and validating suitable analytical methods. If in practice it has been demonstrated they are not formed in the confirmatory studies, these degradation products need not be further examined. Confirmatory studies should then be undertaken to provide the information necessary for handling, packaging, and labeling (see section Procedure , and Presentation , for information on the design of these studies). Normally, only one batch of drug substance is tested during the development phase, and then the photostability characteristics should be confirmed on a single batch selected as described in the Parent Guideline if the drug is clearly photostable or photolabile. If the results of the confirmatory study are equivocal, testing of up to two additional batches should be conducted. Samples should be selec ted as described in the Parent Guideline. Presentation of Samples Care should be taken to ensure that the physical characteristics of the samples under test are taken into account and efforts should be made, such as cooling and/or placing the samples in sealed containers, to ensure that the effects of the changes in physical states such as sublimation, evaporation or melting are minimized. All such precautions should be chosen to provide minimal interference with the exposure of samples under test. Possible interactions between the samples and any material used for containers or for general protection of the sample should also be considered and eliminated wherever not relevant to the test being carried out. As a direct challenge for samples of solid drug substances, an appropriate amount of sample should be taken and placed in a suitable glass or plastic dish and protected with a suitable transparent cover if considered necessary. Solid drug substances should be spread across the container to give a thickness of typically not more than 3 millimeters. Drug substances that are liquids should be exposed in chemically inert and transparent containers. Analysis of Samples At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or color of solution) and for assay and degradants by a method suitably validated for products likely to arise from photochemical degradation processes. Where solid drug substance samples are involved, sampling should ensure that a representative portion is used in individual tests. Similar sampling considerations, such as homogenization of the entire sample, apply to other materials that may not be homogeneous after exposure. The analysis of the exposed sample should be performed concomitantly with that of any protected samples used as dark controls if these are used in the test. Judgment of Results The forced degradation studies should be designed to provide suitable information to develop and validate test methods for the confirmatory studies. These test methods should be capable of resolving and detecting photolytic degradants that appear during the confirmatory studies. When evaluating the results of these studies, it is important to recognize that they form part of the stress testing and are not therefore designed to establish qualitative or quantitative limits for change. The confirmatory studies should identify precautionary measures needed in manufacturing or in formulation of the drug product, and if light-resistant packaging is needed. When evaluating the results of confirmatory studies to determine whether change due to exposure to light is acceptable, it is important to consider the results from other formal Stability studies in order to assure that the drug will be within justified limits at the time of use (see the relevant ICH Stability and Impurity Guidelines) Photostability for Drug Product (Next Article)

Photostability Testing of New Drug Substances and Products: The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change. Normally, photostability testing is carried out on a single batch of material. ( Selection of Batches ) Under some circumstances, these studies should be repeated if certain variations and changes are made to the product (e.g., formulation, packaging). Whether these studies should be repeated depends on the photostability characteristics determined at the time of initial filing and the type of variation and/or change made. The guideline primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. The guideline does not cover the photostability of drugs after administration (i.e. under conditions of use) and those applications not covered by the Parent Guideline. Alternative approaches may be used if they are scientifically sound and justification is provided. A systematic approach to photostability testing is recommended covering, as appropriate, studies such as: i) Tests on the drug substance; ii) Tests on the exposed drug product outside of the immediate pack; and if necessary ; iii) Tests on the drug product in the immediate pack; and if necessary ; iv) Tests on the drug product in the marketing pack. The extent of drug product testing should be established by assessing whether or not acceptable change has occurred at the end of the light exposure testing as described in the Decision Flow Chart for Photostability Testing of Drug Products. Acceptable change is change within limits justified by the applicant. The formal labeling requirements for photolabile drug substances and drug products are established by national/regional requirements. Light Sources The light sources described below may be used for photostability testing. The applicant should either maintain an appropriate control of temperature to minimize the effect of localized temperature changes or include a dark control in the same environment unless otherwise justified. For both options 1 and 2, a pharmaceutical manufacturer/applicant may rely on the spectral distribution specification of the light source manufacturer. Option 1 Any light source that is designed to produce an output similar to the D65/ID65 emission standard such as an artificial daylight fluorescent lamp combining visible and ultraviolet (UV) outputs, xenon, or metal halide lamp. D65 is the internationally recognized standard for outdoor daylight as defined in ISO 10977 (1993). ID65 is the equivalent indoor indirect daylight standard. For a light source emitting significant radiation below 320 nm, an appropriate filter(s) may be fitted to eliminate such radiation. Option 2 For option 2 the same sample should be exposed to both the cool white fluorescent and near ultraviolet lamp. 1. A cool white fluorescent lamp designed to produce an output similar to that specified in ISO 10977(1993); and 2. A near UV fluorescent lamp having a spectral distribution from 320 nm to 400 nm with a maximum energy emission between 350 nm and 370 nm; a significant proportion of UV should be in both bands of 320 to 360 nm and 360 to 400 nm. Procedure For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200-watt hours/square meter to allow direct comparisons to be made between the drug substance and drug product. Samples may be exposed side-by-side with a validated chemical actinometric system to ensure the specified light exposure is obtained, or for the appropriate duration of time when conditions have been monitored using calibrated radiometers/lux meters. An example of an actinometric procedure is provided in the Annex. If protected samples (e.g., wrapped in aluminum foil) are used as dark controls to evaluate the contribution of thermally induced change to the total observed change, these should be placed alongside the authentic sample. Annex Quinine Chemical Actinometry The following provides details of an actinometric procedure for monitoring exposure to a near UV fluorescent lamp (based on FDA/National Institute of Standards and Technology study). For other light sources/actinometric systems, the same approach may be used, but each actinometric system should be calibrated for the light source used. Prepare a sufficient quantity of a 2 percent weight/volume aqueous solution of quinine monohydrochloride dihydrate (if necessary, dissolve by heating). Option 1 Put 10 milliliters (ml) of the solution into a 20 ml colorless ampoule seal it hermetically, and use this as the sample. Separately, put 10 ml of the solution into a 20 ml colourless ampoule (see note 1), seal it hermetically, wrap in aluminum foil to protect completely from light, and use this as the control. Expose the sample and control to the light source for an appropriate number of hours. After exposure determine the absorbances of the sample (AT) and the control (Ao) at 400 nm using a 1 centimeter (cm) path length. Calculate the change in absorbance,  A = AT - Ao. The length of exposure should be sufficient to ensure a change in absorbance of at least 0.9. Option 2 Fill a 1 cm quartz cell and use this as the sample. Separately fill a 1 cm quartz cell, wrap in aluminum foil to protect completely from light, and use this as the control. Expose the sample and control to the light source for an appropriate number of hours. After exposure determine the absorbances of the sample (AT) and the control (Ao) at 400 nm. Calculate the change in absorbance,  A = AT - Ao. The length of exposure should be sufficient to ensure a change in absorbance of at least 0.5. Alternative packaging configurations may be used if appropriately validated. Alternative validated chemical actinometers may be used. Note 1: Shape and Dimensions (See Japanese Industry Standard (JIS) R3512 (1974) for ampoule specifications) Photostability for Drug Substance (Next Article) Photostability for Drug Product (Next Article) Reference: ICH Guideline Q1B

The list of titles of the Code of Federal Regulations The 21 CFR is the Titel 21 for Food and Drugs

Hetero Drugs Ltd. Job Opening for GENERAL MANAGER QUALITY CONTROL Department: Quality Control Experience: 20 to 25 years Location: Nakkapalli Qualification: M.Sc Chemistry Job Description
General Manager QC:
General Manager - Quality Control responsible to oversee the operations of Quality Control functions of Active Pharmaceutical Ingredients(API).
Managing all administrative and technical issues of Quality control Review of analytical results. Ensuring the preventive maintenance and calibration reports as per the schedule Ensuring Good laboratory practices and Laboratory safety standards Responsible for Review of analytical data (worksheet and backup data) received from various sections of QC laboratory Responsible for overall monitoring of Quality Control system Must have exposure of stability management and analytical method validation along with routine commercial and exhibit batch analysis. Responsible for leading operations of QC and ensuring the quality control processes, Review and analysing the results, and offer expertise views. Verify all processes are complying to established specifications, protocols and established quality standards. Ability to represent and lead Audits as front runner Draft, Review, revise and verification of quality standards and Analytical reports and instruct to record and report quality data. Investigate and handle customer complaints of QC and perform root cause anlysis Ensure the team audit readiness and periodical review of performance of quality control systems to ensure efficiency. Ensuring the regulatory compliance of QC as applicable with Comprehensive knowledge of quality control systems, procedures, protocols, standards and regulatory requirements. Should have experience in handling of Regulatory Inspections and the queries and handling of Audits & Regulatory compliance Thorough knowledge of method transfer, method development, technology transfer documents, Qualification and validations Corrective and Preventive actions to address the probabilities of re-occurrences and to fix them Expert in analytical Investigations leading QC team of 200 members , People management skills Developing procedures Periodical review of expenses and budgetary controls Handling of Non-conforming results I.e OOS/OOT - Quality Control - handling out of specification/Out of trends investigations Adhering to the respective standard operating procedures/protocols. Review QMS documents e.g. Change control/Deviation/Incidents-Discrepancy if any To perform periodic and audit trail review of computerized systems in laboratory To support the initiatives undertaken by corporate quality for further strengthening of process, leading change management processes Approve SOPs, Guidelines/Policies as applicable. Guide and mentor QC teams To assess the existing facility and inventories v/s future requirement and offer proposals subsequently Good communication skills and people management with decision making skills, Sound knowledge on QC operations and compliance and thorough knowledge of CSV process
(Preferred Candidate from USFDA approved pharmaceutical API facility ) 20 + years of Experience, At least 15 years experience in Managerial role (Must have the experience in leading of Quality Control in regulatory approved facility only) Email ID talent@heterodrugs.com dharma.ch@hetero.com

Intas Pharmaceuticals, SEZ Ahmedabad Job opening for Quality Assurance - QMS Position SR.OFFICER – SR.EXECUTIVE Experience – 4 –9 Years Education – B.PHARMA / M.PHARMACY Employment Type : Full Time, Permanent Department QUALITY ASSURANCE - QMS Job Location - Ahmedabad (Gujarat) CHANGODAR. Note : candidates should apply resume with mentioned subject code: . OOS / OOT 10, CRF 10, Deviation - 10 Job Description Handling of QMS related activities like change request form, Market complaint, Deviation, CAPA and investigation. Co-ordination and handling of QMS activities in software, monitoring and closing of action plans within the timeline and effectiveness evaluation. Handling and co-ordination of deviation and to perform the investigation/ Risk Assessment and assigning of CAPA. To perform the investigation triggered from Market complaint, ADE, Deviation, Out of Specification (OOS), OOT (Out of Trend), Out of Calibration etc. in software. Preparation of market complaint/ADE, deviations, change request and CAPA review summery. To prepare and co-ordinate investigation study and execution of protocol. & Co-ordination for Quality Review Steering Committee and handling of CAPA initiation from the outcome. Co-ordination for Self Inspection activity i.e. preparation of schedule, Audit planning, Audit Report and Compliance and CAPA. To perform the risk assessment related to process, facility, equipment etc. in co-ordination with cross-functional team members. To review the executed BPCRs and other related documents in relation to deviation, investigation and market complaints. Kindly send your updated resume on meghal_desai@intaspharma.com and jobs@pharmaceuticalguideline.com Meghal Desai Human Resources Intas Pharmaceuticals Limited

Alembic Pharma Vadodara Job Opening for Executive / Sr. Executive Quality Control Qualification: B.Sc,/M.Sc Experience: 1-5 Years all cGMP, GxP, or any other regulatory requirements Role: QA / QC Executive Department: Quality Assurance Employment Type: Full Time, Permanent Job description Roles and Responsibilities
Analysis of In-process, Intermediates, Raw material, Packing material, Finished products, Stability study, Hold time study, Process validation, Cleaning samples, Vendor development, and any analysis allocated by the team leader and release with proper documentation.. • Ensuring analysis is performed in compliance with GLP. • Ensuring analysis of raw data is documented online. • Initiation, Completion, and filing of Daily analysis report. • Ensuring any abnormal results, incidents, deviations, and discrepancies are reported immediately to the reporting Section Head. • Ensuring all relevant log entries are made for every activity wherever applicable. • Supervise compliance to all cGMP, GxP, or any other regulatory requirements including EHS requirements. • Report any quality concerns or suggestions for improvements to Department Head. • Execute and supervise all tasks and activities as per the applicable SOPs and company policy. • To maintain the safety norms while working in the lab. (e.g. Wear goggles, PPE, Disposal of sample/media as per procedure, etc). • Ensuring analysis is performed as per valid procedures and by using calibrated instruments / Standards. • Ensuring self-discipline with respect to wearing aprons, attendance, and personnel hygiene and interrelations. • To perform Labware LIMS-related activities. • Any other assignment was given by the Section Head or Department Head. Interested candidates should submit their rsum and the most recent authorized CTC break up on bhavisha.b@alembic.co.in and jobs@pharmaceuticalguideline.com Contact Personnel Bhavisha Babariya HR Executive at Alembic Pharmaceuticals Limited

Mepro Pharmaceuticals Pvt Ltd, Job Opening for Regulatory Affairs Department [RA] Interested candidates Can Share CV on at hr@mepro.in - 9826586208

Umedica Laboratories- Walk-In Interviews on 23 APR 23

Strides Pharma -Walk-In Drive for WOMEN on 23 APR 23 Mega Walk-In Drive-Strides Pharma-Bangalore “Recruit HER”

Granules India Limited, Walk In Interviews on 22 April 23

Macleods Pharmaceuticals, Walk-In Interview On 2 April 2023 Department: Quality Control/ Production
Qualification: B.Sc/ M.Sc/ B.E/ B.Tech/ B.Pharm/ M.Pharm
Experience: 2 to 08 years
Positions: Officer/ Sr. Officer
Location: Sarigam/ Dahej

Date : 2nd April 2023
Time: 09:00 AM onwards
Venue: VITS Shalimar, Ankleshwar, Valia Road, Near GIDC Reservoir, Ankleshwar, Gujarat