Professional Documents
Culture Documents
QUALITY ASSURANCE
DEPARTMENT OF PHARMACEUTICAL
ANALYSIS
SRM COLLEGE OF PHARMACY,
KATTANKULATHUR
Research
By FDA standards . . .
By comparison . . .
Overall Intent:
To assure Quality is “built in” to the approach.
What is Quality?
GMP:
Protect the integrity and quality of manufactured product
intended for human use.
GLP:
Protect the integrity and quality of laboratory data used to
support a product application.
Current Good Manufacturing Practices
(GMP or cGMP)
Title 21 CFR:
Study Director
58.120 Protocol
(a) “Each study shall have an approved written protocol
that clearly indicates the objectives and all methods
for the conduct of the study.”
Title 21 CFR:
210.1 (a)
210.1 (b)
“The failure to comply with any regulation set forth ... in the
manufacture, processing, packing, or holding of a drug shall
render such drug to be adulterated under section 501(a)(2)(B)
of the act and such drug, as well as the person who is
responsible for the failure to comply, shall be subject to
regulatory action.”
Part 211: Finished Pharmaceuticals
Subpart A: General Provisions
Subpart B: Organization and Personnel*
Subpart C: Buildings and Facilities*
Subpart D: Equipment*
Subpart E: Control of Components and Drug Product
Containers and Closures*
Subpart F: Production and Process Controls*
Subpart G: Packaging and Labeling Control
Subpart H: Holding and Distribution
Subpart I: Laboratory Controls*
Subpart J: Records and Reports*
Subpart K: Returned and Salvaged Drug Products
Organization and Personnel
211.22 (a) Responsibilities of the Quality Control Unit
“There shall be a quality control unit that shall have the responsibility
to approve or reject all ...”
211.34 Consultants
Buildings and Facilities
211.42 Design and Construction Features
(a) “Any building or buildings used in the manufacture,
processing, packing, or holding of a drug product shall be of
suitable size, construction, and location to facilitate cleaning,
maintenance, and proper operation.”
Other Issues:
211.44 Lighting
211.48 Plumbing
211.50 Sewage and refuse
211.52 Washing and toilet facilities
211.56 Sanitation
211.58 Maintenance
Equipment
211.63 Equipment Design, Size, and Location
“Equipment used in the manufacture, processing, packing, or
holding of a drug product shall be of appropriate design,
adequate size, and suitably located to facilitate operations for its
intended use and for its cleaning and maintenance.”
211.72 Filters
Control of Components and Drug
Product Containers and Closures
211.80 General Requirements
(a) “There shall be written procedures describing in sufficient
detail the receipt, identification, storage, handling, sampling,
testing, and approval or rejection of components and drug
product containers and closures; such written procedures shall
be followed.”
211.115 Reprocessing
(a) “Written procedures shall be established and followed ...”
(b) “... review and approval of the quality control unit.”
Packaging and Labeling Control
211.122 Materials Examination and Usage Criteria
(a) “There shall be written procedures ...”
(c) “Records shall be kept ...”
(d) “Labels and other labeling materials for each different drug
product, strength, dosage form, or quantity of contents ...”
(e) “... shall be maintained so that data therein can be used for
evaluating, at least annually, the quality standards of each drug
product to determine the need for changes in ... specifications or
manufacturing or control procedures. Written procedures shall
be established and followed for such evaluations ...”
Records and Reports
211.182 Equipment Cleaning and Use Log
“A written record of major equipment cleaning, maintenance,
and use ...”
Documentation System:
Written procedures (SOPs) must be available for all
operations and activities from receipt of raw materials to
shipment and distribution of finished goods.
SOPs must be followed.
Records must be kept (of everything!)
Also:
Facilities must be appropriate and provide an acceptable
environment to protect product from contamination.
Equipment must be kept clean and well maintained.
Important Documents
In FDA-speak: