Effective documentation practices Documentation System in Pharmaceuticals Industry are essential for ensuring product quality, patient safety, and regulatory compliance in the pharmaceutical industry. Compliance with GDP and other regulatory guidelines is crucial for maintaining the integrity and reliability of documentation throughout the product lifecycle.

OBJECTIVE :

To describe the various documents which control all raw material, packaging components and finished products etc.

SCOPE :

This SOP covers specification and test methods of Raw materials, Intermediate / Bulk products (Inprocess), Packaging components and Finished products.

It also covers Master formula, Batch processing and Packaging Instructions and registration files (factory related technical documents for product registration)

RESPONSIBILITY :

1. Manager Research and Development / Q.C / Q.A Manager are responsible for preparation of Concerned documents.
2. Process related documents are reviewed by Sectional Manager of Production Department.
3. Quality Operators Manager is responsible for approving of concerned documents.
4. Q.O Manager is responsible for final approving of all Manufacturing related documents.

PROCEDURE :

Documentation System in Pharmaceuticals Industry

Preparation of Master Documents.

Specifications :

Specification on Raw materials, Intermediate/bulk materials ( Inprocess), Packaging Components, Finished products are prepared by Q.C / Q.A Manager in accordance with Pharmacoepial, in-house and regulatory Requirements. Certificate of analysis (batch test report) is prepared based on product specification with results for compliance, which is to be attached with batch documents.

These specification are then finally approved by Q.O Manager/ Department Head.

Test Methods :

1. Test methods on Raw material, Intermediate / bulk materials (In-process), Packaging components, Finished products are written by senior Chemist/Quality Assurance Inspector, in accordance with the current Pharmacopeial methods/ internal methods/regulatory requirements.
2. These methods are then revieweded by Q.C / Q.A Manager and finally approved by Q.O.M
3. Master Formula / Process Record Cards (PRC’s):
4. For all New products the Master Formula / Master Processing Instructions are prepared by Senior pharmacist, checked by Production Manager , Approved by Q.O.M
5. For any change in existing Master Formula/Master Processing Instructions or PRCs, Documentation System in Pharmaceuticals Industry are to be updated by using same procedure, as defined in point # 4. jointly by Production Manager & Quality Control Manager and then finally approved by Q.O.M Operations.

One copy of approved Product Record Card is to be handed over to Material and Planning Department for further distribution for batch processing after allotment of batch No.

1. Master Processing Instructions comprises (PIC) of packing ingredients operation sheet which include required quantities of the packing material as per batch size (based on the unit formulation of the product), which has been established during the product development. A batch size is established according to the capacity of the relevent available manufacturing equipments.
2. Manufacturing Instructions:Details of manufacturing steps which is also based on trial batch. These Documentation System in Pharmaceuticals Industry manufacturing steps established during product development if required note for safety and or any special precaution to be taken.Batch reconciliation with allowed deviation, physical parameters and limit for physical parameters for inprocess checks of the product as per requirements & yield data with allowed deviation, For tablets compression data sheets with the description of dies & punches to be used in that particular product. For film coated tablets film coating ingredients assembly sheet detail of film coating steps and yield data for film coated tablets.
3. Physical parameters of pharmaceutical preparation are controlled as per relevant general methods based on Pharmacopeial procedures (Reference general methods) /internal procedures.

Master Batch Packaging Instructions :

1. Master batch packaging instructions are prepared by Senior Pharmacist/ Production Manager and then approved by Q.O.M
2. When the new product is ready for manufacturing and packaging or any change in old products, packaging instruction has to be originated by Quality Assurance Manager.
3. Pack size will be as per packaging components as mentioned in registration certificate and batch size will be as per Product Record Card.
4. Packaging instruction shall has per pack quantity of the components and also batch size quantity of components.

Batch Manufacturing / Packing Flow Procedure

1. Approved PRC (Master Formula / Batch processing instructions) for a batch is raised by Production Planning and Control Department with the allotment of a unique Batch No. and handed over to Materials Department.
2. The Material Department dispenses the material according toas per PRC in the presence of authorized persons of Production the Department.
3. Materials are received by Production Department with the entry of Amount required, Amount issued, Control No.in “Ingredient Assembly Operation” sheet. This document is signed by designated persons of Material and Prod-uction Department in the “Issued by” and “Received by” columns.
4. The PRC is handed over to Production Department.
5. The concerned section commences operation as per instructions described in the PRC. Each step of the operatiom once completed, is signed by the Processor and checked and countersigned by the Supervisor or designated person of the Production Manager.
6. When the batch is processed until a stage (Intermediate/Bulk form), it is sampled by Quality Assurance Inspector.
7. The samples are checked for physical characteristics by Q.A department and is analysed chemically by Q.C department as per product specification (Certificate of Analysis QAD/IV/0000).
8. After satisfactory physical and analytical results the batch is released for further processing by Q.C Manager.
9. Upon completion of the batch, final sampling is to be carried out by Quality Assurance Inspector.
10. All Inprocess records/Quality Control results are attached with the BMR.
11. Thereafter, the batch is transferred to Packaging department via BMR after released by Quality Control.
12. The Packaging department packs the products as per approved packaging instructions using relevant documents./ instructions. (viz. Line Clearance, Inprocess controls etc.)
13. After packaging samples are taken by Quality Assurance Inspectors for reference.
14. The batch is transferred to Finish Goods Warehouse via Transfer Note after batch reconciliation by production department
15. The batch documents with transfer note after reconciliation are delivered in Quality Assurance department.
    for document review.
16. After document reviewed by Quality Assurance Inspector, the document is finally reviewed and signed by Q.A Manager or his designee.
17. After signing of the transfer note (Altogether three copies) by Q.A Manager or his designee, the batch is Assistant Manager Quality Control and Q.A Officer.
18. One of the copies is retained by Quality Assurance Department along with the other batch documents other copies are distributed to Warehouse and Accounts one each.
19. All documents including test reports (Certificate of Analysis), Inprocess records pertaining to the batch are retained as “Batch History” along with the relevant check list and are kept in Quality Assurance Department for two year more than the expiry period of the product.

Factory Related Technical Documents for Product Registration:

1. When a new product is approved factory related technical documents are prepared by RND Manager. It contains following details regarding the product to be registered.
2. Product unit formulation, raw material specification references, manufacturing summary, inprocess controls, analytical method for product (based on pharmacopeial method/corporate method), product specification (based on Pharmacopeial standard / internal standard, shelf life specification and shelf life stability data in support of shelf life.
3. The above data is compile and send to Regulatory Manager for onward submission to Ministry of Health.

Document Coding System :

1.  All products are assigned unique reference numbers as given in Master List of products.
2. Abbreviations for documents are :

M : Master Formula / Process Record Card (PRC)
P.I. : Packaging Instructions
A : Testing Methods
C : Certificate of Analysis