👉PHARMACEUTICAL NOTES👈
👀 List of SOPs required in QA department?
SOP for format preparation,
change control, SOP for SOP, deviation, Non-conformance products, market
complaints, product recall, returned goods, vendor qualification, preparation of
BPCR & MPCR, Assigning of Mfg. date & Expiry date, annual product
review, corrective action & preventive action, process validation, cleaning
validation, equipment qualification, glossary of terms, document control,
Review of BPCR & analytical test report, batch numbering
system, labeling practice,
personnel training, BPCR issue and retrieval, batch release, self inspection
(internal audit), file numbering system, preparation of organo-gram,
preparation of COA,
specimen signatures, Reprocess & rework of intermediates / API, Job
responsibilities, Technology transfer, measurable quality objectives etc.
👀What is Intermediate?
A material produced during steps of the
processing of an API that undergoes further molecular change or purifications
before it become an API
👀What is an API?
Any substance or mixture of substances
intended to be used in the manufacturing of a drug (medicinal) product and that
when used in the production of a drug, becomes an API of the drug product. Such
substances are intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment or prevention of disease
or to affect the structure & function of the body
👀What is Drug substance (API)?
Any substance or mixture of substances
intended to be used in the
manufacture of a drug product
and that, when used in the production of a drug, becomes an active ingredient
of the drug product. Such substances are intended to furnish pharmacological activity or
other direct effect in the diagnosis, cure, mitigation, treatment.
👀What is Drug product?
The dosage form in the final immediate
packaging intended for marketing
👀Clean rooms classifications?
Clean rooms are classified in
to the following types as per different guidelines:
Schedule M: Grade A, Grade B,
Grade C, Grade D
USFDA (US 209E): Class 1,
Class 10, Class 100, Class 1000,
Class 10000, Class 100,000
WHO 2002: Grade A, Grade B,
Grade C, Grade D
EU GMP: Grade A, Grade B, Grade
C, Grade D
ISO 14644-1: ISO-3, ISO-4,
ISO-5, ISO-6, ISO-7, ISO-8, ISO-9
Britian (BS 5295): Class C,
Class D, Class E or F, Class G or H,
Class J, Class K
Australia (AS 1386): 0.035,
0.35, 3.5, 35, 350, 3500
Germany (VDI 2083): 1, 2, 3,
4, 5, 6
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