SOP for the Preparation of the Master Formula Record

Purpose

To provide instructions for the preparation of the Master Formula Record.

Objective

To provide a documented procedure for the preparation of the 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, instructions & precautions or any other information related to the product.

Scope

This procedure is applicable for the preparation of the Master Formula Record in the QA department at PharmaInfo Ltd.

Responsibility

Follow up: Officer – QA

Overall responsibility: QA Manager.

Procedure

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

• The name of the product, together with the product reference code relating to its specifications.
• The proprietary name of the product, along with the generic name, the strength of the product, and the batch size.

• Mention the 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.
• The master document must also contain the statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, wherever applicable.
• Include a statement of the processing location and the principal equipment to be used.
• It must include the methods or the reference to the methods to be used for preparing the critical equipment, including cleaning, assembling, and calibration.
• Detailed stepwise processing instructions and the time taken for each step must be clearly mentioned.
• The instructions for In-process controls with their limits.
• The requirements for storage conditions of the products, including the container, labeling, and special storage conditions wherever applicable, must be mentioned.
• Any special precautions to be observed must be included.
• Include Packing details and specimen labels relating to the product

Abbreviations

QA: Quality Assurance

SOP: Standard Operating Procedure

Revision History

Nil

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