Quality Control (Lab and Lot Release)
What the exam tests
Questions cover analytical validity, pharmacopoeial standards, out-of-specification handling and the batch release decision - with particular attention to biologicals.
Standards and method control
Pakistan does not apply a single national pharmacopoeia in routine use; the Drugs Act recognises official pharmacopoeias (British Pharmacopoeia, United States Pharmacopeia and others), so a specification must cite an official monograph or a validated in-house method. Methods are qualified or validated for the matrix; reference standards must be traceable and within expiry; instruments need calibration and a written log. Data must satisfy ALCOA+ - attributable, contemporaneous, original, accurate, complete, with an audit trail.
Out-of-specification
An OOS result is not a reason to retest until it passes. Phase I is a laboratory investigation for assignable cause; Phase II extends to manufacturing. Retesting is permitted only under a written, approved plan with a defined number of replicates; invalidating a result needs documented justification.
Lot release
Every batch is released by an authorised person against the batch record and finished-product testing. Biologicals - vaccines, blood products, biosimilars - additionally require official batch release by the national control laboratory before distribution, with summary lot protocol review and, for imports, the lot release documentation from the country of origin. Retain samples for the required period and keep the batch in a stability programme.
Worked example
A tablet batch assays at 94.0% against a 95.0–105.0% specification. A second analyst repeats it and gets 95.2%. Without an investigation that is testing into compliance; the correct route is an OOS investigation covering sample handling, standard preparation and the method itself.
Traps
Averaging an OOS with a pass; using an expired reference standard; releasing a vaccine batch without national control laboratory release; accepting a supplier's certificate of analysis as your own release decision.