Industrial Pharmacy · Short notes

Good Manufacturing Practice: Short Notes & Cheat Sheet

What GMP covers: personnel, premises and clean areas, equipment, documentation and data integrity, production controls, complaints and recalls.

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Short notes

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The areas GMP controls

A failure in any one area can compromise every batch, which is why GMP inspections look at all of them.

Principles

GMP is the part of quality assurance that ensures products are consistently made and controlled to the quality suited to their use.
It is often summarised as the '5 Ps': people, premises, processes, products and procedures.
International references are WHO GMP and PIC/S. In Pakistan, GMP requirements are set out in the rules made under the Drugs Act 1976 and enforced through DRAP inspections.
Quality cannot be tested into a product; it has to be built in at every step.

People, premises and equipment

Staff must be qualified, trained and follow hygiene rules. The heads of production and quality control must be independent of each other.
Premises are laid out for one-way flow of materials and people, to prevent mix-ups and cross-contamination.
Dedicated, self-contained facilities are needed for highly sensitising products such as penicillins, and often for cephalosporins, cytotoxics and certain hormones.
Clean areas are graded A to D. Grade A (like ISO 5, laminar air) is for aseptic filling, grade B surrounds it, and grades C and D are for less critical steps. HVAC keeps pressure differences between rooms.
Equipment is qualified (DQ, IQ, OQ, PQ), calibrated, cleaned to validated procedures and recorded in log books.

Documentation and control

'If it isn't written down, it didn't happen.' Key documents: specifications, the master formula, SOPs, batch manufacturing records and batch packaging records.
Data integrity follows ALCOA+: attributable, legible, contemporaneous, original and accurate (plus complete, consistent, enduring and available).
Production controls include line clearance before each batch, in-process checks and yield reconciliation.
Deviations are investigated and fixed through CAPA (corrective and preventive action). Changes go through change control.
Retention samples of each batch are usually kept for at least a year after expiry. Complaints are investigated and recalls classified by risk.
Recall classes: class I (serious health risk or death), class II (temporary or reversible harm) and class III (unlikely to cause harm).

Cheat sheet

High-yield facts in one place. Cover the right-hand column and test yourself.

Clean area grades

Grade	Used for
A (≈ ISO 5)	Aseptic filling, open sterile product
B	Background for grade A
C	Preparing solutions to be filtered
D	Handling components after washing

Quick GMP facts

Item	Detail
ALCOA	Attributable, Legible, Contemporaneous, Original, Accurate
Class I recall	Serious risk to health or life
Line clearance	Before every batch or product change
Dedicated facilities	Penicillins (and other sensitisers)
CAPA	Corrective and preventive action
BMR	Batch manufacturing record

Memory aids

ALCOA: Data must be Attributable, Legible, Contemporaneous, Original and Accurate.

Exam traps

QC testing alone cannot guarantee quality; GMP builds it into the process.
The heads of production and QC must not report to each other.
Penicillins need dedicated, segregated facilities because of sensitisation risk.
A class I recall is the most serious, not the least.

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