Transcript No Slide Title

MANUFACTURING
DOCUMENTS
TYPE OF GMP DOCUMENTS
QUALITY MANUAL
S.O.P.
Master production
document
Master Formula
Master Prod.
Procedure
Master Pack. Procedure
Testing
Specification/ Method
Standard
Work Protocol
(WP)
Identity/
Label
Raw & packaging material
Validation Protocol
Bulk
Finished product
Equipment Status
Material Status
Product Status
Report
Sampling record
Testing result record and report
Microbial and particle monitoring record
Stability test record
Batch Production Record
Return Product Handling Record
Recall Record
Product Destruction Record
Note :
•Blue: WI (standard, specification & procedure)
Product Complaint Record
•Red: Record
Distribution Record
Manufacturing Records
• Master Formula Record
• Batch Manufacturing Record
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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:
Reproduction Reviewed for Accuracy:
1 of 10___________________________
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
appropriate entries.
Checked by: ________________
3. Make sure all raw materials to be used are
properly identified and are released for
use.
Checked by: ________________
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
operation.
5.
The Process Operator will test for accuracy
all scales and/or balances involved in the
manufacturing operation before any weighing
is done.
Checked by___________________
Tested by: __________________
Checked by: _________________
Manufacturing Batch Record
Processing Steps
5. While mixing with Sweep, ADD:
INV NO. Purified Water
XXX. Kg.
Date weighed_______________________
Gross______________________________
Tare ______________________________
Net _______________________________
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
Tare__________________kg
Net___________________kg
Scale Used______________________ kg
Total Weight
_kg
Weighed by_______________________kg
Checked by_______________________kg
Date
Time___________kg
Gross_________________kg
Tare__________________kg
Net___________________kg
Scale Used______________________ kg
Total Weight
_kg
Weighed by_______________________kg
Checked by_______________________kg
Date
Time___________kg
Manufacturing Batch Record
Yield Determination/Sign Off
Yield:
Theoretical Yield:___________________________
Calculate percentage yield
.
Actual Yield:
kg
% 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
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Content
Format
Approval and Storage
Change Control
• In Process Controls, Specifications, and Results
• Product Labels
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Preparation
Ordering
Proofing
Acceptance
Counting
- Storage
- Inventory
- Dispensing
- Reconciliation
- 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
QC DEPARTMENT
QC DEPARTMENT
QUARANTINE
APPROVED / RELEASED
MATERIAL / PRODUCT NAME
BATCH NO
INTERNAL CODE
SAMPLING DONE BY
:
:
:
:
…………..
…………..
…………..
…………..
SIGN
DATE
: ….....
: ….....
MATERIAL / PRODUCT NAME
: …………..
QC TESTING REPORT NO
: …………..
SIGN
: ….....
TESTING DONE BY
: …………..
DATE
: ….....
EXPIRE DATE
: …………..
RETESTING SHOULD BE DONE
: …………..
QC DEPARTMENT
QC DEPARTMENT
BEING RETESTED
REFUSED / REJECTED
MATERIAL / PRODUCT NAME
BATCH NO.
SUPPLIER / PRINCIPLE NAME
QUANTITY
:
:
:
:
…………..
…………..
…………..
…………..
TESTING DATE
………….
SAMPLING BY
………….
MATERIAL / PRODUCT NAME
BATCH NO.
QC TESTING REPORT NO
TESTING DONE BY
:
:
:
:
…………..
…………..
…………..
…………..
SIGN
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
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Sampling
Labeling
Sample Control
Testing
– Methods
– Specifications
Result Handling
Out of Specification Result Handling
Approvals
Record Maintenance and Security
REFERENCES
1. ASEAN Guidelines for Cosmetic GMP (2003)
2. WHO EDM, Basic Principle of GMP:
Documentation part 1 and 2 (2004)
3. Wirjadidjaja E.C, Good Documentation Practices,
Jakarta (March 2005)
4. Soenardi F, Document Creation, Jakarta (March
2005)