Transcript Good Manufacturing Practices

Good Manufacturing Practices
What is it?
How is it carried out?
The Early Beginnings
 1900’s house-calls
 Home remedies,
ointments and miracle
elixirs
 Entertainment and
music
 No regulations until
1902
Food and Drug Administration Assures
Safety in Drugs it Approves
History of control of drugs, food, cosmetics sold to the public:
 1905- The Jungle by Upton Sinclair - Meatpacking
industry led to the Food and Drug Act against unsanitary
conditions
 1937-Sulfanilamide caused death in children
Control over the purity and effectiveness led to
Federal Food, Drug and Cosmetic Act (1938)
 1941 -Carry out clinical trials to determine the efficacy and
toxicity (Insulin)
 1962 -Thalidamide tragedy leads to testing of drugs for
side effects
A Time Line of GMP continued
1963
Establishment of GMP’s for Drug and
Production
1966- 1968 Packaging is accurate/Drug
Manufacturing Sanitary and Drug is
effective
1978
cGMP’s for Drugs and Devices established
1979
GLP’s final rules written
1988
Food and Drug Administration is formed
and has an appointed commissioner
Premises & Equipment
 The premises and equipment must be located,
designed, constructed, validated and maintained
to support the intended operations
 Lay out, design and operation must be designed
so as to minimize the risk of errors and permit
effective cleaning
 Adequate and safe provision of lighting, heating
ventilation, power, gases, water and drainage.
Premises and Equipment-GMP
 There should be defined storage areas for
quarantine, released, rejected and recalled
materials.
 Where specific storage conditions are required
these should be provided, checked and monitored
for compliance.
 Storage areas should be secure, restricted to
authorised person access.
Premises and Equipment- GMP
 Adequately specified prior to purchase
 Validated correctly before being put into use and
when in use
 All equipment must have a serial number
 All equipment should be calibrated, cleaned and
maintained according to written instructions
Documentation - Why?
1.Clarity of procedures __ Standard Operating Procedures
Approved :QualityAssurance
2.Confirmation that correct procedures are followed
__ Reviewed by Quality Assurance
supervisors, personnel
3.Allows for corrective measures to determine best to use
__ Reviewed by Quality Control
Management and
Production
Documentation Included - GMP
 Keep procedures, instructions, specifications,
records.
 Write in a clear concise and unambiguous way.
 Review regularly and controlled.
 Records are kept in ink
 Alterations to a record should be signed and
dated but must be signed by an authorised
person.
Production/Procedures - GMP
 Must follow clearly defined procedures and be
performed by trained and competent staff
 Significant amendments or changes to the
production process that may affect the quality of
the product or reproducibility of the process
should be validated.
Good Manufacturing Practices
Audits
Training
 Internal Audits by QA, QC
 Records showing
and Production will
 External Audits carried out
by the Food and Drug
Administration
 FDA can issue a warning,
and eventually stop
production
consistent review of
training of staff
 Training includes
 New personnel
 Change in regulations
 Change in process
Change Control
 Written procedures should be in place to
describe actions
 All changes and/or deviations that affect product
quality
 Reproducibility of the process should be
formally requested documented and accepted.
Production/Procedures - GMP
 Validation studies should show that the process, equipment