Saturday, November 20, 2010
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. :