1.0 Objective
To describe the procedure for preparation of Master Formula Record.
2.0 Scope
This SOP applies to the preparation of Master Formula Record.
3.2 Secondary Responsibility: Quality Assurance Department
3.0 Responsibility
3.1 Primary Responsibility: F&D and Production Department3.2 Secondary Responsibility: Quality Assurance Department
4.0 Accountability
Head- Quality Assurance shall be accountable for implementation of the SOP.
5.2 Master Formula Record (MFR) shall be prepared as per the format attached to this SOP.
5.3 Master Formula Record (MFR) shall be divided into two parts as shown in the attached Format - Manufacturing part and Packaging part.
5.4 The first page of both the sections shall have following details:
5.4.1 Name, Address and Logo of the Company.
5.4.2 Dosage Form:
5.4.3 Brand Name:
5.4.4 Generic Name:
5.4.5 Product Code:
5.4.6 Label claim: This should include all ingredients and text included in product permission.
5.4.7 Product description:
5.4.8 Batch Size:
5.4.9 Pack size: This should describe the packing style of salable pack and sample pack. This should be expressed in terms of the number, weight or volume of the product in the final container.
5.4.10 Shelf life:
5.4.11 Storage condition:
5.4.12 Drug schedule: Whether schedule "H" or schedule "G" drug.
5.4.13 Superseded Master Card No. and date:
5.4.14 Present Master Card No. and date:
5.4.15 Present Master Card effective B. No.:
5.4.16 Reference of change control number:
5.5 There shall be authorization on all pages of Master Formula Record (MFR) by three persons i.e. person who shall prepare the Master Formula Record (Production Officer), the person who shall check the Master Formula Record (Production Head) and the person who shall finally approve (Quality Assurance Head) it. All the three persons will sign off all the pages. Their designation and their name will be printed below their signatures along with the date of signing the document.
5.6 The second page of manufacturing section shall include - Process steps to be monitored.
5.7 Subsequent pages shall include the processes to be monitored. The stage-wise movement of the material in a form of flowchart. The flow chart shall cover all activities beginning from the dispensing of the materials and ending at the transfer of a batch to finished stores.
5.8 The list of equipment, machines, utensils to be used, shall be described.
5.9 The subsequent page shall include any special precautions to be taken for the product during manufacturing and packing. The same page should also include Batch Manufacturing Formula. The batch formula should have following columns:
5.9.1 Serial number
5.9.2 Name of ingredients
5.9.3 Reference of the specification of ingredients
5.9.4 Quantity to be added (in mg per ml or per tablet or per capsule or per gram as the case may be)
5.9.5 Overages to be added (in %)
5.9.6 Quantity to be added per batch or per lot
5.10 Below that give the calculation steps for every active material, ensuring that the active materials shall be compensated for assay values less than 100 % which could be due to less potency or higher moisture content.
5.11 In subsequent page, include manufacturing process. Write the process stage wise and stepwise. At the end of every important stage, include a statement of the yield with acceptable limits.
5.12 Include in-process quality checks during and at the end of important steps and stages with their limits.
5.13 The process shall include the process equipment to be used. The methods or the reference of the methods/ procedures to be employed for preparing, cleaning, assembling, operating the various equipment shall be given.
5.14 Include detailed stepwise processing instructions (e.g. checks on materials, pretreatments, the sequence for adding materials, mixing times, temperatures, humidity etc.).
5.15 Include the requirements for storage conditions of the products.
5.16 The packing part of Master Formula Record (MFR) should include a complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types.
5.17 Include line clearance checking during batch coding and batch packing operations.
5.18 Include reconciliation of printed and unprinted packing materials with acceptable limits.
5.19 Include destruction of excess or rejected printed packing materials.
5.20 Include description of packaging operation including any significant subsidiary operations and equipment to be used. Include details of in-process controls with instructions for sampling and acceptance limits.
5.21 Include reconciliation of the packing yield with acceptable limits.
5.22 Finally include batch release procedure.
6.2 SOP: Standard Operating Procedure
6.3 No.: Number
6.4 e.g.: Example
5.0 Procedure
5.1 Production Department in association with F&D, shall prepare Master Formula Record (MFR).5.2 Master Formula Record (MFR) shall be prepared as per the format attached to this SOP.
5.3 Master Formula Record (MFR) shall be divided into two parts as shown in the attached Format - Manufacturing part and Packaging part.
5.4 The first page of both the sections shall have following details:
5.4.1 Name, Address and Logo of the Company.
5.4.2 Dosage Form:
5.4.3 Brand Name:
5.4.4 Generic Name:
5.4.5 Product Code:
5.4.6 Label claim: This should include all ingredients and text included in product permission.
5.4.7 Product description:
5.4.8 Batch Size:
5.4.9 Pack size: This should describe the packing style of salable pack and sample pack. This should be expressed in terms of the number, weight or volume of the product in the final container.
5.4.10 Shelf life:
5.4.11 Storage condition:
5.4.12 Drug schedule: Whether schedule "H" or schedule "G" drug.
5.4.13 Superseded Master Card No. and date:
5.4.14 Present Master Card No. and date:
5.4.15 Present Master Card effective B. No.:
5.4.16 Reference of change control number:
5.5 There shall be authorization on all pages of Master Formula Record (MFR) by three persons i.e. person who shall prepare the Master Formula Record (Production Officer), the person who shall check the Master Formula Record (Production Head) and the person who shall finally approve (Quality Assurance Head) it. All the three persons will sign off all the pages. Their designation and their name will be printed below their signatures along with the date of signing the document.
5.6 The second page of manufacturing section shall include - Process steps to be monitored.
5.7 Subsequent pages shall include the processes to be monitored. The stage-wise movement of the material in a form of flowchart. The flow chart shall cover all activities beginning from the dispensing of the materials and ending at the transfer of a batch to finished stores.
5.8 The list of equipment, machines, utensils to be used, shall be described.
5.9 The subsequent page shall include any special precautions to be taken for the product during manufacturing and packing. The same page should also include Batch Manufacturing Formula. The batch formula should have following columns:
5.9.1 Serial number
5.9.2 Name of ingredients
5.9.3 Reference of the specification of ingredients
5.9.4 Quantity to be added (in mg per ml or per tablet or per capsule or per gram as the case may be)
5.9.5 Overages to be added (in %)
5.9.6 Quantity to be added per batch or per lot
5.10 Below that give the calculation steps for every active material, ensuring that the active materials shall be compensated for assay values less than 100 % which could be due to less potency or higher moisture content.
5.11 In subsequent page, include manufacturing process. Write the process stage wise and stepwise. At the end of every important stage, include a statement of the yield with acceptable limits.
5.12 Include in-process quality checks during and at the end of important steps and stages with their limits.
5.13 The process shall include the process equipment to be used. The methods or the reference of the methods/ procedures to be employed for preparing, cleaning, assembling, operating the various equipment shall be given.
5.14 Include detailed stepwise processing instructions (e.g. checks on materials, pretreatments, the sequence for adding materials, mixing times, temperatures, humidity etc.).
5.15 Include the requirements for storage conditions of the products.
5.16 The packing part of Master Formula Record (MFR) should include a complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types.
5.17 Include line clearance checking during batch coding and batch packing operations.
5.18 Include reconciliation of printed and unprinted packing materials with acceptable limits.
5.19 Include destruction of excess or rejected printed packing materials.
5.20 Include description of packaging operation including any significant subsidiary operations and equipment to be used. Include details of in-process controls with instructions for sampling and acceptance limits.
5.21 Include reconciliation of the packing yield with acceptable limits.
5.22 Finally include batch release procedure.
6.0 Abbreviations
6.1 QA: Quality Assurance6.2 SOP: Standard Operating Procedure
6.3 No.: Number
6.4 e.g.: Example
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