2. OBJECTIVES
1. To understand where the regulations come from,
who has enforcement authority, and why you
need to comply
2. To understand the “Fundamentals”,
“Benefits” and “Key Parts” of cGMPs
3. WHAT ARE CGMPS?
Current Good Manufacturing Practices
Come from the Food Drug and Cosmetic
Act
Rules set up by the FDA that drug
manufacturers needs to follow in order to
ensure that a safe and effective product is
manufactured
4. WHY GMP?
• Provides a high level assurance that medicines are
manufactured in a way that ensures their safety,
efficacy and quality
• GMP applies to both Active Pharmaceutical
Ingredients (APIs) and Finished Pharmaceutical
Products (FPPs)
7. FDA
Center for Biologics Evaluation
and Research (CBER)
Center for Devices and
Radiological Health (CDRH)
Center for Drug Evaluation
and Research (CDER)
Center for Food Safety and
Applied Nutrition (CFSAN)
Center for Veterinary Medicine
(CVM)
National Center for Toxicological
Research (NCTR)
Office of the Commissioner (OC) Office of Regulatory Affairs
(ORA)
THE FDA CONSISTS OF EIGHT BRANCHES
8. FUNDAMENTALS OF CGMPS?
• Quality Control, safety, and effectiveness must be
designed and built into the product
• Quality cannot be inspected or tested into a finished
product
• Each step of manufacturing must be controlled to
maximize the chances that the Finished Good will be
acceptable
9. WHAT ARE THE BENEFITS OF CGMPS?
They outline a Quality System that reduces or prevents
errors
Ensures products are safe for use in humans
Prevent/control contamination and cross-contamination
Minimizes variations in potency of the drug
Ensures reproducible physiological activity
Prevent side effects and toxicity due to variations in
drug content and potency
Prevents mislabeling and adulteration
10. HOW WE PURCHASE AND
STORE RAW MATERIALS
OUR BUILDING
LABELLING &
PACKAGING
THE PRODUCTION &
DISTRIBUTION OF OUR
PRODUCTS
OUR RECORDS
OUR
EQUIPMENT
11. GOOD MANUFACTURING PRACTICES
1. Quality assurance
2. Sanitation and hygiene
3. Qualification and validation
4. Product recalls
5. Contract production and analysis
General
The contract giver
The contract accepter
The contract
12. GOOD MANUFACTURING PRACTICES (CONT'D)
6.Self inspection and quality audits
Items for self-inspection
Self-inspection team
Frequency of self-inspection
Self-inspection report
Follow-up action
Quality audit
Suppliers’ audits and approval
7. Training
13. GOOD MANUFACTURING PRACTICES (CONT'D)
8. Building and Facilities
General
Ancillary areas
Storage areas
Weighing areas
Production areas
Quality control area
9. Equipment
14. GOOD MANUFACTURING PRACTICES (CONT'D)
10. Materials
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected, recovered, reprocessed and reworked materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous
15. GOOD MANUFACTURING PRACTICES (CONT'D)
11. Documentation or Records
Documents required:
Labels
Testing procedures
Specifications for starting and packaging materials, for
intermediate and bulk products and for finished products
Master formulae and Batch Processing Records
Packaging instructions and Batch Packaging Records
Standard Operating procedures (SOP's) and records
Logbooks
16.
17. HOW WE PURCHASE AND
STORE RAW MATERIALS
OUR BUILDING
LABELLING &
PACKAGING
THE PRODUCTION &
DISTRIBUTION OF OUR
PRODUCTS
OUR RECORDS
OUR
EQUIPMENT
18. KEY PARTS OF CGMP’S
Subpart B: Organization and Personnel
Subpart C: Buildings and Facilities
Subpart D: Equipment
Supbart E: Control of Components and Drug Product Containers
and Closures
Subpart F: Production and Process Controls
19. KEY PARTS OF CGMP’S
Subpart G: Packaging & Labeling Control
Subpart H: Holding & Distribution
Subpart I: Laboratory Controls
Subpart J: Records & Reports
Subpart K: Returned & Salvaged Drug Product
20. ENGAGED IN SUPERVISION OF MANUFACTURE
PROCESSING, PACKING AND HOLDING OF PRODUCT
Adequate number
……to perform assigned task or function to give
assurance of product quality, identity, purity.
Sufficient
Education
Training Experienc
e
23. HYGIENE AND
SANITATION
WHY IS HYGIENE AND SANITATION
IMPORTANT?
Man is a natural carrier of microorganisms.
These are expelled when we
SNEEZE (BUMAHIN)
COUGH (UMUBO)
YAWN (HUMIKAB) TALK (NAGSALITA)
27. Cover your hair which
have dust & germs.
Prevent hair from
falling into the
product.
Cover the nose and
mouth which are
natural reservoir of
germs. Trap particles
or droplets from the
nose and mouth.
28. Street shoes
contain germs
from the soil and
dirt we stepped
on, so it must not
be worn inside the
plant, plant shoes
must be used
instead.
Cover finger nails
and hands which
have germs.
29. HANDLING OF GLOVES
1) Place gloves in a clean plastic bag during break time.
2) Wash gloves with soap and water after use. Dry and
sanitize.
30. HYGIENE AND SANITATION
PRACTICES
*Wash hands with
soap and water
After using the toilet
Before starting to work
After blowing your nose
After handling dirty things
After touching body surface
After eating
31.
32. BUILDINGS AND FACILITIES
• Buildings must be designed with adequate size and space for
operations (helps to eliminate mix-ups)
• Facilities must be validated
• There must be a good flow pattern for personnel, materials,
products and waste materials (flow from clean to dirty)
• The facility must be easy to clean and sanitize (surfaces,
equipment, exposed cords, floors, ceilings…)
• Environmental controls must be in place (clean rooms)
• Utilities must be validated (water systems, electrical, etc)
33. BUILDINGS AND FACILITIES
• Must have engineering documents describing the layout of the
clean rooms – controlled documents
• Changes to the layout of the room after it has been validated
must go through change control procedures and may require
revalidation of the room
• Any changes that potentially impact the ventilation in the room
must be assessed for impact on the microbial levels in the
room
• Microorganisms, particulates, and hazardous materials must
be controlled
34. EQUIPMENT
• Equipment should be selected based on the intended use
and cleanability if it is to be in a clean room
• Equipment must be placed in an appropriate location
(temperature, humidity, etc.)
• Equipment must be properly qualified (Design,
Installation, Operation, Performance)
35. MUST NOT REACT WITH OR ABSORB ANY OF THE
COMPONENTS THEY CONTACT.
39. ALL MATERIAL RECEIPT MUST BE
IN GOOD CONDITION
CLEAN AND IDENTIFIED
Intact, no damage
RAW
MATL’S
RAW
MATL’S
40. And must be protected from damage by outside
elements such as wind, rain and insects.
It helps prevent
mix-ups and
errors!!
All components
must be stored
in a safe and
orderly way . . .
41. Reserve samples for
every approved
component…..
Clearly identified
Kept for at least
one year after the
expiration of the
Product
A rejected component must be
properly identified and kept
separate until it is disposed
of.
42. FOLLOWING SOP’S IS VITAL
…….AND SO ARE THE RECORDS WE KEEP!
•SOP’s
•RECORDS
43. No one changes the SOP’s…
Manufacturing and Control
Monographs
...until it has been approved by
the heads of Manufacturing and
Quality Control
44. REASONS FOR WRITING PROCEDURES
AVOID/MINIMIZE
MIX-UPS AND ERRORS
ENSURE CONSISTENT
QUALITY
ENSURE COMPLIANCE
WITH GMP
REGULATION
45. PACKAGING AND LABELING CONTROL
Label is a display of a written, printed or graphic matter
upon the immediate container of any article
Labeling is the label and any other packaging material or
container that is printed (ex. IFU, advertising materials)
Procedures must exist that document receiving, identity,
storage, handling, sampling, and testing of labels and
ensure that integrity is maintained throughout production
and use of product
46. PACKAGING AND LABELING CONTROL
Labeling must be separated physically in storage to avoid mix-ups
Wording of labels cannot be changed unless the FDA is
notified
Labeling must be inspected prior to issuing to production
All labels must be reconciled (accounted for) if not 100%
inspected.
Label control begins with the design
47. PREPARATION FOR PACKAGING & LABELLING
Packing lines and Packaging lines
must
machines must be be identified with
cleaned and inspected proper identifying
Lot Number.
Every thing is ready to roll when Quality Control and Production give
the approval
Ok
GO!!
Ok
GO!!
GO!! GO!!
48. The packaging
department
follows the
packaging directions
for each
individual lot.
This includes
affixing the lot
number and
expiration date.
The packaging directions are very important part of the
Batch Production Record.
It’s All
here!!
49. ALL CONTAINERS MUST PROVIDE
PROTECTION FROM EXTERNAL
CONTAMINATION
It’s no
use!!!
Everything is
tightly sealed!!
50. ALL CONTAINERS MUST BE STORED SAFELY ……………….
…………….TO PREVENT DAMAGE AND CONTAMINATION
51. ACCURATE RECORD KEEPING IS VITAL …….
RECORDS MUST BE FILLED OUT AT THE TIME
WE COMPLETE THE JOB!!!
When did
I do….
that?
52. DON’T TRUST YOUR MEMORY!!
RECORDS MUST BE FILLED OUT AT THE TIME
WE COMPLETE THE JOB!
Maintenance
&
Cleaning
Record
53. RECORDS AND REPORTS
• Quality Records are the proof that the procedures were
followed and they show traceability of product.
• Examples:
– Lot History Records
– Laboratory Notebooks
– Protocols
– Reports
– Logbooks
– Distribution Records
– Complaint Files
54. BATCH PRODUCTION RECORDS MUST BE
CAREFULLY FOLLOWED AND
MONITORED…..
……..THROUGHOUT THE PRODUCTION PROCESS
QUALITY
CONTROL
MANUFACTURING
55. QUALITY RECORDS
• Records are legal documents and can be subpoenaed in a court of
law as evidence
• Signatures on documentation have the same meaning as on any
kind of contract
• Information must be recorded and signed for at the time of
performance on the original record
57. SUMMARY AND CONCLUSIONS:
GMP compliance is not an option
Quality should be built into the product
GMP's are very similar and are really Good Common Sense
Good Practices cover all aspects of manufacturing activities
prior to supply
The role and involvement of senior management is crucial
