In-Process, Finished, Raw Material, Packing Material analysis, Calibration of Instruments, handling of QMS, Specification, STP, SOP, OOS, OOT, Change control, Deviation, AMV, Sampling, HPLC , UV, TOC, Potentiometer, Stability, Team leading, Training.

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USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS

Personal hygiene requirements in the pharmaceutical industry

Good Chromatography Practices for the pharmaceutical industry

Granules; a General Chapter of British Pharmacopoeia BP and Europian Pharmacopoeia Ph Eur

The VMP serves as the validation roadmap, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that ensure a continuing state of validation.

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…

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…

Conductivity: It is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present.

VALIDATION MASTER PLAN (VMP)
Level 1 Document in the Pharmaceutical industry.

Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ,

User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry,

Basic interview questions
How to calculate the requirement of commercially available Concentrated HCl to prepare 0.1N or 0.1M HCl Solution?

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Design Qualification [DQ]
Gives assurance that the premises, systems, equipment have been designed for their intended use as per GMP norms.