Instructions for the preparation of Master Formula Record.

1.0         Purpose     :    To provide instructions for the preparation of Master Formula Record.

2.0         Objective   :   To provide a documented procedure for the preparation of Master Formula Record.

Master Formula Record is that standard manufacturing / packing record which gives complete details of materials used along with their quantities, standard process flow, Area & equipment used, Yield and reconciliation, Instruction & precautions or any other information related to product.

3.0                  Scope    :    This procedure is applicable for the preparation of Master Formula Record in QA department at ------ Pharmaceuticals, .

4.0         Responsibility   :

§          Follow up               :                  Officer – QA

§          Over all responsibility    :         Q.A Manager.

5.0       Procedure  :

·        Any Master document prepared relating to the plant must include following: -

Ø     The name of the product together with product reference code relating to its specifications.

Ø     The proprietary name of the product along with the generic name, strength of the product and batch size.

Ø     Mention-Name, quantity, and reference number of all the starting materials to be used.  Also any substance that may ‘disappear’ in the course of processing must be mentioned.

Ø     The master document must also contain the statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where ever applicable.

Ø     Include a statement of the processing location and the principal equipment to be used.

Ø     It must include the methods or the reference to the methods, to be used for preparing the critical equipment including cleaning, assembling and calibration.

Ø     Detailed stepwise processing instructions and the time taken for each step must be clearly mentioned.

Ø     The instructions for In-process controls with their limits.

Ø     The requirements for storage conditions of the products, including the container, labeling and special storage conditions wherever applicable must be mentioned.

Ø     Any special precautions to be observed must be included.

Ø     Include Packing details and specimen labels relating to the product

6.0      Reference Document  :   Not applicable

7.0      Abbreviations   :

·        QA   = Quality Assurance department

·        SOP = Standard Operating Procedure

8.0      Copies to Distribution Sites.  :

·        QA

·        Production