21 CFRChanges in 21 CFR Part 11 Subpart C, Electronic Signatures
Update on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic…
Validation
15 articles
21 CFR
News and UpdatesICH Q9(R1) Quality Risk Management: Summary & Changes
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Manufacturing and PackagingWHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
QAPeriodic Review and Requalification
Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained
QAPerformance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
QAOperational Qualification (OQ): Protocol, Tests & Examples
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
QAInstallation Qualification [IQ]
The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
QASite Acceptance Test [SAT]
Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
QAFactory Acceptance Test (FAT) in Pharma: Checklist & Scope
Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.
QADesign Qualification [DQ]
Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…
QAUser Requirement Specification (URS) in Pharma + Template
User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
QABasic Flow of Qualification [Equipment, Utility, System, Facility] in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ
GeneralVALIDATION MASTER PLAN (VMP)
VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.
GeneralGranules Dosage Form: Definition, Types & Advantages
Granules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur
QAINSPECTION OF UTILITIES
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021