PMQA cGMP

Specifications

criteria to which a drug product should

conform to be considered acceptable quality for its

intended use.

quality assurance

group within the manufacturer that determines

that the systems and facilities are adequate, and that

the written procedures are followed to ensure that the

finished drug product meets the applicable

specifications for quality

Administrative Order no. 220 s. 1974

Guidelines promulgated by the USFDA

Quality control and Production control

Good Manufacturing Practices (GMP) is a

responsibility of:

safe, pure and effective.

Objective of cGMP

Component

means any ingredient intended for use in the

manufacturing of drugs, including those that may

not appear in the finished product

Batch

means a specific homogenous quantity of a

drug or in case of drug produced according to

single manufacturing order during the same

cycle of manufacture.

Lot

means a batch or any portion of

a batch of a drug, produced by a

continuous process

Lot number

means any distinctive combination of

letters and/or numbers, or both, by

which the complete history of the

manufacture, control, packaging and

distribution of a batch or lot of a drug is

determined.

Active Ingredient

means any

substance of a drug, which is

intended to furnish

pharmacological activity

Inactive Ingredient

means any

substance other than “Active

Ingredient” present in the drug

formulation.

Materials Approval Unit

means any

organizational element having the

authority and responsibility to approve

or reject raw materials, in-process

materials, packaging components and

final products.

Strength

means (a) the concentration

of a known active drug substance in the

formulation (b) potency, that is, the

specific ability or capacity of the product

as indicated by appropriate lab

5 years

records and samples are

retained for a period

of the

last drug batch produced using the

master-formula records;

A Master formula records shall be

retained for a period of at least?

hermetic container

container for air

product recall

worst case for not doing proper checking

central release station

station for safekeeping and storage

red

color label for rejected

yellow

color label for quarantine

green

color label for approved

90-110%

potency standard

quality assurance

for group

qc

under QA