batch formula record and master formula record
- 1. Batch formula record and Master Formula record Presented by: Rashmita Poojary (19) Komal Regude(20) T.Y.B.PHARM ➢Master formula record: ➢ Definition: A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specific quantity of a finished product as well as the processing instruction, including the in- process controls. ➢ Master production instructions should include: • The name of the intermediate/ API / formulation being manufactures and an identifying document reference code if applicable. • Complete list of raw material and intermediate. • An accurate statement of the quality or ratio of each raw material or intermediate to be used, including the unit of measures. Variation to quantities should be included wherever justified. • The production location and major production equipment to be used • Where appropriate, special notations and precautions to be followed, or cross reference to these • Instructions for the storage of the API or intermediate formulation to assure its suitability for use; instructions should cover the labelling and packaging material and special storage conditions with time lines. • Equipment: A list of all required equipment and machines required in the manufacturing process with their capacity. • Flow chart: Steps of the manufacturing process to be monitored. Flow charts of the material movement from dispensing to the final product to stores. • Special instructions: Write down the precautions special instructions to follow during the product manufacturing and packing. • Calculations: Include the calculation steps of all active materials to get the 100% of the active material. • Manufacturing Process: Write all the steps in all stages of the manufacturing process including steps like shifting, milling, mixing, lubricating, granulation, compression and coating should be written in detail including the process time and yield. • Packing Process: List of all packing materials with their quantity is written. • Yield: Include the theoretical, actual yield and acceptance limit of the batch. ➢ Master formula record must include: Ranges of the process parameters Sequence to be followed The methods to be used for preparing the critical equipment's Sampling instructions and in process control Time limits Expected yield ranges at appropriate phases of process. Name, address and logo of the company, Dosage form, Brand Name, Generic name, Product code, Label claim name. Present Master card number and Date, Effective Batch number, Reference of changed control number. Product description: batch size, pack size, shelf life, storage conditions, drug schedule. Superseded Master card number and Date. Superseded Product code ➢ Procedure to prepare a Master Formula Record: A Master Formula Record is either prepared based upon experience of competent qualified staff like manufacturing chemist or analytical chemist or prepared based upon batch manufacturing record of a batch size. We can’t ignore Master formula record at any level. ➢ Steps in preparation of MFR: • MFR shall be divided into two parts: 1. Packaging part 2. Manufacturing part ➢ The first page of both must include: ➢ The secondary page of manufacturing section shall include: ▪ Process steps to be monitored. ▪ Subsequent pages shall include the processes to be monitored. ▪ The list of equipment, machines, utensils to be used, shall be described. ▪ 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 ➢ At the end of every important stage, include a statement of the yield with the acceptable limits. • Include in-process quality checks during and at the end of important steps and stages with their limits. • The process shall include the process equipment to be used. • Include detailed stepwise processing instructions (example: checks on materials, pretreatments, sequence for adding materials, mixing times, temperatures, humidity etc.) • Include the requirements for storage conditions of the products. • The packaging part of MFR should include complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types. • Include line clearance checking during batch cording and batch packaging operations. • Include reconciliation of printed and unprinted packaging materials with acceptable limits. • Include destruction of excess or rejected printed packaging materials. • Include description of packaging operation including any significant subsidiary operations and equipment’s to be used. ➢Batch Manufacturing record: ➢ Definition: BMR is written document of the batch, prepared during pharmaceutical manufacturing process. KEYPOINTS Every batch has its own BMR Actual data and step by step process All stages are included in BMR from issuance of raw material to finish product. Documentation proof are attached to BMR during its production. BMR contains all the batch histoery and product data . BPR should be prepared for each intermediate and API ➢ The following information should be recorded in BPR/BMR at the time each action is taken: • The name of the product, batch number, the quantity of product to be packed, as well as the quantity actually obtained and its reconciliation. • The date and time of packaging • The name of the person responsible • The initials of the operators • The checks made for identity and conformity • The details of packaging operation • Regular checks • Notes on any deviation • The quantities and reference number. Reference: Quality Assurance- PV book https://www.pharmaguideline.com/2015/05/batch-manufacturing-record-bmr.html https://www.pharmaguideline.com/2016/07/preparation-of-mfr-for-pharmaceuticals.html ➢ Documentation of completion of each significant step in the BPR should include: • Date and time • Identity of major equipment used. • Specific identification of each batch. • Recorded result for critical process parameters • Any sampling performed. • Signatures of the person performing and supervising critical steps in the operation. • In process and laboratory test result • Yield at appropriate phases or time. • Description of packaging • Representative Label • Any deviation, evaluation and investigation conducted. • Results of release testing • All analytical records • Quality control information • The product record review. Permanent Signed Legible Accurate Original The Ideal BMR must be: