SOP on Master Manufacturing Records
(Master Formulae)
1.0 Purpose: This SOP describes the guidelines for manufacturing operations in preparation of a batch of drug product and information’s to be recorded.
2.0 Scope: This SOP applies to Production Staff and Quality Control Staff.
3.0 Responsibility: Quality Assurance Manager to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: The basis of all manufacturing operations is master formula which enables a manufacturer to achieve uniformity from batch to batch of a drug product. All calculations are checked by competent persons for accuracy and signed by these individuals. Master formulae are prepared for each drug product, dosage form and batch size are kept in lock and key under supervision of production manager.
Master formulae records include following –
1. Name of product and dosage form.
2. Batch size
3. Description of a fixed formulation:
a. Name of each ingredient (active / inactive)
b. Weight / measure of each ingredient per unit / weight / measure of finished product.
c. Accurate statement of total quantity / amount of each ingredient
d. The amount and percentage of overages for each ingredient where applicable
4. Description of dosage, statements of unit dose for each active ingredients
5. Calculations of theoretical yield and limits for manufacturing loss or gain
6. Description of detailed manufacturing instructions including proper sequence, description of equipments to be used and precautions to be observed.
7. List of intra-process control wherever applicable and tolerance limits for their results –
a. For liquids: Clarity, volume, pH, re-dispersion etc.
b. For capsules / tablets: Average weight, weight variation, hardness, friability, dissolution and disintegration time.
c. For dry syrups: average weight, weight variation, and pH.
8. A complete description of containers, closures and packaging materials to be used.
9. Specimen of approved labels / unit cartons etc. associated with retail or bulk packs.
10. Names of responsible personnel, dates for preparation and verification.
11. Approval by Quality Assurance personnel for every modifications in the master formulae.