GMP
PRINCIPLES OF GMP
1. Writing detailed step by step procedures that provide controlled and consistent
performance .
2. Carefully following written procedure to prevent contamination and probable errors
3. Accurately documenting work for compliance .
4. Proving that system that assigned for validation work
5. Integrating productivity , quality of products and employee safety into the constructi
on and construction of facilities and equipments .
6. Maintain facilities and equipments
7. Clearly defining , developing and demonstrating job competency
8. Protecting products from contamination by making cleanliness as a daily habit .
9. Building quality into products by systematically controlling components and product
related process such as manufacturing , packaging , labelling , testing , distribution
and marketing .
10. Performing planned and periodic audits for compliance and performance .
5 P’s of GMP – People
premises
processes
products
procedures
GMP focuses on food, beverages , cosmetics , pharmaceutical products , dietary
supplements and medical devices
c GMP certification – before requesting c gmp declaration a certificate of
pharmaceutical products must be obtained . It is the only export certificate issued by
FDA . The national authorities of EU member issue GMP certificate within 90 days
after inspection .
TYPES OF REGULATORY DOCUMENTS
A. Protocols
B. Clinical study report ( CSR)
C. Common technical document (CTD)
D. Informed consent form (ICF)
E. Risk management plan ( RMP)
GMP guidelines for active pharmaceutical products
a) Manufacturing processes are clearly defined and controlled to ensure consistency
and compliance with approved specification .
b) Critical steps of manufacturing processes are validated .
c) All necessary key elements are provided -:
qualified and trained personnel
adequate premises and facilities
suitable equipments and utilities
correct material , containers and labels
approved procedures and instructions
suitable storage and transport
d) Instructions and procedures are written in clear and umabiguous language
e) Operators are trained to carry out procedure
f) All quality related activities should be recorded at the time they are performed
g) Records of fabrications , packaging , labelling , testing , distribution , importation
and wholesalling are retained .
h) Control of storage , handling and transport
i) Recalling of API s from sale .
J) Complaints about API s are examined , defects are investigated and appropriate
measures are taken .
GMP guidelines for training –
Types of training –
Induction programme – conducted by HRD dept through quality assurance
department .
On job training – list of topics for training is prepared by HOD
Class room training – conducted by faculty from the company or outside
Outside training – HOD is to nominate name of employee for outside training .
Retraining list is prepared by head of quality assurance and head HRD .
GMP guidelines for personal hygiene
Watches , necklaces , chains , bracelets , earring , rings and exposed piercing should
not be worn except medic alert jewellery.
Fingernails polish , false eyelashes or fingernails , badges , pins should not be worn
Glass and brittle material should not be brought into food handling and storage
areas except eyewear .
Personnel should not eat , drink , smoke , chew gum or tabocco , spit or take
medication in food handling and storage areas .
guidelines for clothing like to wear coat etc
DOCUMENTATION –
Procedure to follow
a) Records
b) Labels – applied to containers , equipment shall be clear and in company
agreed format. Different colours of labels like green meant accepted , red
means rejected
c) Specifications – should be available for raw material , finished products ,
packaging material . Each specification shall be approved and maintained by
quality assurance . Specification to comply with – national pharmacopaecia
eddition and drug rules 1978
d) Master formulae
e) Packaging instruction
f) Batch manufacturing records (BMR) –
g) Batch packaging records – by name and signature , the name of product ,
batch no , quantity , date and time of packaging , name of respective person
, expiry date .
h) Standard operating procedures (SOP)
