11.GMP

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TYPE OF GMP DOCUMENTS

QUALITY MANUAL

S.O.P.

Testing Equipment Status


Master production Specification/ Method Work Protocol Identity/ Material Status
document Standard (WP) Label Product Status
Master Formula Raw & packaging material
Master Prod. Bulk Validation Protocol Report
Procedure
Master Pack. Procedure Finished product Sampling record
Testing result record and report
Microbial and particle monitoring record
Batch Production Record Stability test record
Return Product Handling Record
Recall Record
Product Destruction Record Note :
Product Complaint Record •Blue: WI (standard, specification & procedure)
Distribution Record •Red: Record
Manufacturing Records
• Master Formula Record
• Batch Manufacturing Record
– Content
– Format
– Approval and Storage
– Change Control
• In Process Controls, Specifications, and Results
• Bulk Storage and Labeling
GMP RECORDS
•Another type of documentation is the form used for
recording data as it is taken during the performance
of tasks, tests, or events.
•These are forms (datasheets, or data record forms),
reports, batch processing records, and equipment
log books.
•These documents provide the evidence that the raw
materials, facility environment, the production
process, and the final product consistently meet the
established quality requirements.
•Record legibly in permanent ink
RECORDS MAINTENANCE
Check whether control records are maintained for:
a.Raw materials and primary packaging materials,
documenting disposition of :
released materials
rejected materials.
b.Manufacturing of batches, documenting the:
kinds, lots and quantities of material used.
processing, handling, transferring, holding and
filling.
sampling, controlling, adjusting and reworking.
code marks of batches and finished products.
c.Finished products, documenting sampling, individual
laboratory controls, test results and control status.
d.Distribution, documenting initial interstate shipment,
code marks and consignees.
FINISHED PRODUCT SPECIFICATION
Finished product specification should include:

 Designated name, and internal code reference if


applicable
 Master Formula number
 Description of finished product and its package details
 Qualitative and quantitative requirement with
acceptance limits
 Direction for sampling and testing, or reference to an
approved procedure
 Storage condition or precautions, if any
 Shelf life, if any
 Batch numbering requirement (including manufacturing
date or expiry date )
MASTER FORMULA
The master formula should be available upon request.
A printed master formula and manufacturing instructions for each
product must be prepared, endorsed, and dated by the owner,
manager, or competent person delegated by management.
Wherever possible a second competent person should check,
reconcile, endorse, and date formula instructions.
The master formula can be divided by :
processing master formula
packaging master formula
Transcription from the master documents should be by
photocopying or computer printout. A competent person should
initial each document before issue to signify that it is complete,
legible and appropriate. Instructions should preferably be printed.
BATCH PROCESSING RECORD
Should be prepared for each batch of product.
Each Batch Processing Record should include the following :
name of product
batch or code number
master batch formula and number
brief processing process
processing date and yield
identity of individual major equipment & lines or location used
records of cleaning of equipment used for processing as
appropriate
in-process control and laboratory results, such as pH and
temperature test records
any sampling performed during various steps of processing
any investigation of specific failure or discrepancies
results of examinations on bulk products
PROCESSING MASTER FORMULA
The master processing documents should include at least
the following :
a.product name
b.batch size
c.a description of the product (form, color, odor, etc)
d.a list of all materials and the quantity to be used
e.equipment to be used and processing location;
f.theoretical or expected yield;
g.adequate step-by-step directions for manufacture:
precautions to be taken with regard to product and
personal safety
equipment to be used and how to clean it to
prevent cross-contamination;
sequence of adding materials;
mixing times, temperatures;
in-process control and storage condition
BATCH PROCESSING RECORD
The manufacture of the batch must proceed in accordance with these
documents, and the following must be included:
a.the actual weights of materials and, where given, the unique
identifying number. These weights should, where possible, be
independently checked, and both weigher and checker should initial
the record sheet;
b.the initials of the operator or supervisor for each step immediately
after it has been performed;
c.the actual yield;
d.a record of all samples taken and the results of tests performed;
e.the batch number which specifically identifies it and distinguishes
it from all other batches;
f.where applicable, a date after which the product must not be used.
MFG Batch Record Header
MANUFACTURING LOG SHEET

M.F.# Title:___________________________________________________

Date Approved:_________________________Approved by:________________________________

Date Checked:__________________________Checked by:_________________________________

Replaces Page No.:_____________________Dated:______________________________________

Date Written:__________________________Written by:_________________________________

Mfg. Lot. No.:_________________________Mfg. Date:__________________________________

Batch Size: ___________________________Page: 1 of 10___________________________

Reproduction Reviewed for Accuracy: Date:__________


MFG Batch Record
Preliminary Precautions
PRELIMINARY PRECAUTIONS:

1. Check the resistance of the water to be Resistance


used. Water resistance must be greater
than one megohm. Checked by: ________________

2. Check all equipment for cleaning status


stickers. Check Equipment Log Book for Checked by: ________________
appropriate entries.

3. Make sure all raw materials to be used are


properly identified and are released for Checked by: ________________
use.

4. The Process Operator will check to see that


all scales and/or balances of sufficient
capacity and sensitivity are available for
each weigh out required in the manufacturing Checked by___________________
operation.

5. The Process Operator will test for accuracy


all scales and/or balances involved in the Tested by: __________________
manufacturing operation before any weighing
is done. Checked by: _________________
Manufacturing Batch Record
Processing Steps

5. While mixing with Sweep, ADD: Date weighed_______________________


Gross______________________________
INV NO. Purified Water Tare ______________________________
Net _______________________________
XXX. Kg. Scale used_________________________
RMC No.____________________________
Nos. entered by____________________
Weighed by Checked by_______
Added by Checked by_______
Sweep on Checked by_______

-------------------------------------------------------------------------------------
6. Mix for 10 minutes with Sweep. Time started Checked by_______
Time finished Checked by_______
Sweep ON__________Checked by_______
Manufacturing Batch Record
Sampling/Bulk Storage
Take one aseptic micro sample and two 4 oz. test samples from each drum as it is
being filled. Record Net Weights:

Drum #1 Drum #2

Gross_________________kg Gross_________________kg
Tare__________________kg Tare__________________kg
Net___________________kg Net___________________kg
Scale Used______________________ kg Scale Used______________________ kg
Total Weight _kg Total Weight _kg
Weighed by_______________________kg Weighed by_______________________kg
Checked by_______________________kg Checked by_______________________kg
Date Time___________kg Date Time___________kg
Manufacturing Batch Record
Yield Determination/Sign Off
Yield:

Theoretical Yield:___________________________ Actual Yield: kg

Calculate percentage yield . % Calculated by______________

Checked by_________________

If Yield is greater than 100% or less than 90% Production Supervisor will investigate
and justify.

Remarks ____________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

PRODUCTION AND CONTROL RECORDS REVIEWED AND APPROVED BY:

PRODUCTION DATE___________

QUALITY CONTROL DATE___________


PACKAGING MASTER FORMULA
The master packaging documents must include at
least the following where applicable:
a.the name of the product;
b.the contents of the primary container by volume or
weight;
c.a reference to the specification of all materials
required for the packaging and labelling of the product;
d.any special instructions or precautions, including area
clearance check
e.Description of packaging process;
f.In-process control, with sampling instruction;
g.provision for calculation of yield or reconciliation.

An accurate copy of the master packaging and labelling


instructions must be made for each batch of product
before it is manufactured.
BATCH PACKAGING RECORD
Should be prepared for each batch of product.
Each Batch Processing Record should include the following :
name of product
batch & code number
batch formula and brief packaging process
packaging date
Theoretical and actual yield
identity of individual major equipment & lines or location used
records of cleaning of equipment used for packaging process
in-process control and laboratory results, such as volume and
product weigh
packaging line clearance records
Expiry date, if shelf life is less than 30 months
any investigation of specific failure or discrepancies
disposition and identity of quarantine label
Packaging Records
• Packaging Records
– Content
– Format
– Approval and Storage
– Change Control
• In Process Controls, Specifications, and Results
• Product Labels
– Preparation - Storage
– Ordering - Inventory
– Proofing - Dispensing
– Acceptance - Reconciliation
– Counting - Returns
LABELING SYSTEM
•Labeling systems are used to identify :
the status of the material, product, equipment ,
laboratory reagent, or facility
restricted areas, and
warning labels.

There are 2 classes of labels :


label for finished products
label used within the factory to control process

Reference standards (both primary and secondary)


must be appropriately labeled and the issuance must
be controlled
PRODUCT STATUS LABELS
QCDEPARTMENT QCDEPARTMENT

QUARANTINE APPROVED/ RELEASED


MATERIAL/ PRODUCTNAME :…………..
MATERIAL/ PRODUCTNA
M E :…………..
BATCHNO :………….. QCTESTINGREPORTNO :………….. SIGN :….....
INT
E RNA
LC ODE :………….. S
IGN :… ..... TESTINGDONEBY :………….. DATE :….....
SAMPLINGD ONEBY :………….. DATE :…..... EXPIREDATE :…………..
RETESTINGSHOULDBEDONE :…………..

QCDEPARTMENT QCDEPARTMENT

BEINGRETESTED REF
U SED/ REJECTED
MATER IAL/ PRODUCTNAME :………….. TESTINGDA
TE MATE RIAL/ PRODUCTNA
M E :…………..
BATCHN O . :………….. …………. BATCHN O. :…………..
S
U PPLIER/ PRINCIPLENA
M E :………….. S
A MPLINGBY QCTE STINGR EPORTNO :………….. S
IGN :… .....
QUANT IT
Y :………….. …………. TESTINGD O NEBY :………….. DATE :….....
QUALITY CONTROL RECORD
Record for each testing, assay result and release or
rejection of starting materials, intermediates, bulk and
finished product should be maintained.

QC record may consist of :


date of test
identification of the material
supplier name
date of receipt
original batch number if any
batch number
quality control number
quantity received
date of sampling
quality control results
Quality Control Testing
• Sampling
• Labeling
• Sample Control
• Testing
– Methods
– Specifications
• Result Handling
• Out of Specification Result Handling
• Approvals
• Record Maintenance and Security
REFERENCES

1ASEAN Guidelines for Cosmetic GMP (2003)


2WHO EDM, Basic Principle of GMP: Documentation
part 1 and 2 (2004)
3Wirjadidjaja E.C, Good Documentation Practices,
Jakarta (March 2005)
4Soenardi F, Document Creation, Jakarta (March
2005)

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