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

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
C The master formula should be available upon request.
C 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.
C The master formula can be divided by :
processing master formula
packaging master formula
C 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

Content
Format
Approval and Storage
Change Control

In Process Controls, Specifications, and Results

Product Labels

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

C Record for each testing, assay result and release or
rejection of starting materials, intermediates, bulk and
finished product should be maintained.
C 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
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)