CGMP Sec 5-8

Christine Joy H. Acosta, RPh, MSc

Section 5
Storage of Starting and packaging Materials, Intermediates,
Bulk Products and Finished Products
Risk of mix-up and
contamination
Stored off the floor
Suitable environmental condition
Proper storage
Temperature
Secured containers
Outdoor storage
Storage warehouse
Delivery to returning
Inventory system
Written explanation
Documentation
All RM and PM shall be
checked
Proper identity
Condition of container
Approval of QC
REJECTED separated
from APPROVED
Printed PM shall be stored
in restrictive storage area
and dispensed under strict
supervision
FEFO
Re-testing of RM
Stable (every 1-2 yrs)
Flavors (ever 6 mos)
Highly unstable ( every
mo.)
Documentation
Info on supplier
Batch and Lot no.
No. of containers
Date of receipt, release
and expiry
Section 5
Storage of Starting and packaging Materials, Intermediates,
Bulk Products and Finished Products
REJECT
ED
QUARANTI
NE
APPROVE
D
Assignment of Reference
and Control No.
Material Specification
Unauthorized
abbreviations, codes or
names shall not be used.
Visual Inspection!
Listing of standard
names of chemical
materials shall be
abbreviated for reference
Quarantine until
approved!
Status Labels (attached
by authorized personnel
only)
Highly unstable matls
must be stored in strictly
controlled temp room
Maintenance of Stock
Record
Segregated dispensing
area
Cytotoxic, Antibiotics,
Hormones
Reject materials shall be
conspicuously identified,
locked, destroyed and
returned to supplier
Section 5
Storage of Starting and packaging Materials, Intermediates,
Bulk Products and Finished Products
Intermediat
e
Bulk Finished
Section 5
Storage of Starting and packaging Materials, Intermediates,
Bulk Products and Finished Products
Pending until quality control testing and disposition
Countercheck materials delivered with delivery
documentation
Each container shall be checked for proper
identification and condition
SUSPECTED identity or condition retained in
quarantine
BASIC MANUFACTURING
REQUIREMENTS
Equipments
Technically suitable
Well-sited
Easy to clean and maintain
Inert
Factory sanitation and Personal
Hygiene
Manufacturing facilities and
methods must be designed to
prevent cross-contamination
Sufficient space
Section 6
Production
Performance
reliability of equipment
System
Consistency and reproducibility of procedure
Significant changes in process must be validated
Process Validation retrospective approach
Air
Water
Personnel
Surfaces in contact with the product
Regular monitoring
Contamination
Consistent from Processing Packaging
No repetition
Properly recorded
Batch and Lot Numbering System
Section 6
Production
Method from handling to dispensing must be written and
properly documented
Prior to weighing & dispensing: check name and sticker color
Check equipment capacity
Always be CLEAN!
2 personnel for weighing
1 production supervisor for checking
Weighing and Dispensing (GRAY AREA)
Ensure LINE CLEARANCE (before during after
production)
All in-process intermediate and bulk controls shall be
accurately recorded at the time of performance, signature and
time must be affixed
Actual Yield must be recorded vs. Theoretical yield
(Reconciliation)
Processing
Section 6
Production
% yield = (A Y / TY ) * 100
% loss = [( TY- AY ) / TY] * 100
Enclosed dust collecting systems
Effective dust extraction system
Use of GLASS equipment is to be avoided
Check equipment before and after use
Dry Materials and Products
Equipment shall be fitted with dust control system
Critical operating parameters ( time, speed & temp) must be
monitored
Filter bags fitted to fluid bed dryers shall be SPECIFIC to 1
product
Solutions and suspensions shall be freshly prepared and
consumed.
Mixing and Granulation
Section 6
Production
Tablets removed for testing and other purpose must not be
returned to the batch
Rejected and Discarded tablets shall be properly identified and
quantity shall be RECORDED!
Compression
(Tablet Weight, Thickness, Diameter and Hardness)
Air supplied to coating pans must be filtered
Coating solutions shall be prepared in separate cubicle
Coating
Empty capsule shells must be stored appropriately to prevent
drying and brittleness
Hard Capsule Filling
Section 6
Production
Closed-system production
Equipment design should include a min. of dead-legs or sites
where residues can accumulate
High quality stainless steel
Potable water with accepted microbial count
Accurate measuring system (ex. Dipstick)
Maintain homogeneity
When finished product is not immediately packed, the maximum
period of storage and the storage condition must be specified
and adhered to.
Liquids, Creams and Ointments
Section 6
Production
Section 7
Packaging
Details of the operation shall be recorded on the Batch Packaging Record
Pre-coded labels shall be strictly controlled
Stored in sealed containers
With proper security and segregation
Coding must be done in isolated area
Control of pre-printed packaging materials
Code numbers
Bar codes
All approved pre-printed packaging materials shall be stored separately in restricted
locked area
Pre-printed materials shall not be over-printed with a different name, dosage form
and strength of the product
Section 7
Packaging
Ensure LINE CLEARANCE
Must be checked by supervisor and documented indicating date and
affix signature
Always check the expiration date!
Expiry date calculated from the date of the final processing stage of
the product before packaging
Shelf life + Date of manufacture
Unused, damaged and defaced packaging materials shall be counted
or closely estimated
Item reconciliation
In-process control shall be followed
Point of sampling
Frequency of sampling
No. of samples to be taken
Specifications, limits and acceptability (Minor, Major, Critical
defects)
Product fill or count shall be checked at the start of a packaging
run
Results must be documented.

Examples (Production IPQC):
Weight uniformity
Hardness & friability
Tablet thickness
Tablet disintegration
Section 7
Packaging
Risks of packaging errors can be minimized by the ff:
Use of roll-feed labels
On-line batch coding
Use of electronic code readers and label counters
Labels and other printed materials designed with distinct
marks for different products
Visual checking

3 Types of Labels:
Gang-printed
Cut (individual)
Roll
Section 7
Packaging
Section 7
Packaging
Products of similar appearance shall not be packaged in close proximity
In each packaging line Name and Batch of the product being packaged shall be
displayed.
Containers must bear proper labels
Packaging personnel must be well-trained
Any printed packaging matl found during clean up shall be returned to supervisor for
reconciliation and destruction
Compressed air shall never be used to clean equipments
Brushes shall be restricted
On the completion of the packaging operation, the last production package shall be
carefully checked to confirm that it fully agrees with the master packaging procedure.
Section 7
Packaging
Only finished goods shall be placed on a pallet
A responsible person shall oversee the counting and destruction
of non-returnable products
All unused coded matls shall be reconciled and destroyed
Any unexplained yield discrepancies or failure to comply with the
specifications must be thoroughly investigated.
Section 8
Finished Product Quarantine and Delivery to Warehouse
Finished goods are held in QUARANTINE area until
approved by QC for release (except items for testing)
Special storage conditions should be catered.
Final QC release:
Finished products meet QC requirements for all processing
and packaging specifications
Sufficient retention samples
Acceptable reconciliation of printed packaging components
Finished goods reconciled with transfer documents
Antibiotics (requires batch certification by FDA)
Retention Samples:
1 yr after expiry
2 yrs after complete market distribution
5 yrs after date of manufacture
Whichever is the shortest
Section 8
Finished Product Quarantine and Delivery to Warehouse
A system designated to control shipment FE FO
The system must generate records from which the
distribution of each batch or lot of drug product can be
readily determined to facilitate investigation or recall if
necessary
Written procedures describing the distribution of products
shall be established and followed.