Revised Schedule M · WHO-GMP · EU-GMP · US FDA — on site and remotely
Experience across the dosage forms and container systems below allows each system, layout and document set to be written for the form in front of it, rather than adapted from a generic template.
A validation package for an ampoule line has little in common with one written for a tablet block. What follows is where the work has actually been done.
One coherent document set, built so that a single library satisfies the State licensing authority, a WHO or EU inspector and an export customer.
Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 · Revised Schedule M — premises, plant and equipment, pharmaceutical quality system, quality risk management, product quality review and computerised systems · Schedule U records · State FDCA and CDSCO licensing, layout approval and inspection.
21 CFR Part 210 and Part 211 · 21 CFR Part 11 for electronic records and signatures · FDA expectations on process validation lifecycle, investigation quality and data integrity.
EU GMP Volume 4, Parts I and II · Annex 1 for sterile medicinal products in its revised form · Annex 11 computerised systems · Annex 15 qualification and validation.
WHO TRS good manufacturing practice guidance · WHO-GMP certification and Certificate of Pharmaceutical Product · documentation expectations applied by WHO-aligned national authorities.
ICH Q7, Q8, Q9 and Q10 · PIC/S principles of good manufacturing practice · requirements applied by African and Latin American health authorities in facility inspection and product registration.
Facility inspections faced and supported in quality leadership roles, together with customer, institutional and third-party audits across sterile and non-sterile operations.
Preparation for an inspection is not a document exercise. It is the rehearsal of the people who will answer, against the questions that authority actually asks — and the evidence being on the shelf when it is asked for.
How an assignment runsTell us the dosage forms on the licence, the markets you supply or intend to, and the authority or customer you are preparing for. The answer will state plainly what fits, what does not, and where the effort belongs first.