A pharmaceutical product’s master formula record (MFR) serves as a reference for other documents. Everything you need to know about making the product may be found here. Research and development staff create MFR, which is then used by manufacturing units to generate additional papers, such as BMRs and BPRs.
Master Formula Record:
A variety of titles have been proposed for this record, including: master formula record, master manufacturing record, master production record, and others. The Master Formula Record is the moniker we’ve given it. The most critical part of any production process is maintaining high levels of consistency. Every time we make it, we require the same product in every batch. There shouldn’t be much of a variation between two batches of the same product. The master formula record is critical in ensuring process consistency. A tangible copy of the master formula record must be on hand throughout the production process, whether it is created electronically or manually.
A master formula record may be defined in what way?
Each batch has a record of the product name, production method, ingredient and composition requirements, equipment utilized, batch size and dosage form, intermediate and final yields, storage conditions and step-by-step instructions, etc. Used in the production process as a standard. Technical workers, such as industrial chemists and analytical chemists, draught and approve a master formula record. All manufacturing steps for each product and batch size should be documented in a master formula record. In order to fully grasp a standard procedure, a master formula record should provide a thorough explanation or reference code.
Contents of Master Formula Records:
- The product’s name and product reference code, both of which link to its specifications
- Dosage form, strength, product composition, and batch size are all described in detail.
- An excipient used in conjunction with the product’s components as well as its patent-protected name.
- Noting the content that can be lost in the production process as a special consideration
- Each and every ingredient/excipient utilized in the production process is described in detail, along with a unique reference code.
- A detailed description of the location and machinery utilized in the operation, as well as their requirements (such as cleaning and assembling and calibrating and sterilizing)
- Every stage of the procedure is explained in depth, including the amount of time it takes to complete it.
- Quality control instructions, sample collection instructions, and other in-process testing instructions are all included in this section.
- For the product’s storage and processing conditions as well as its packaging and labelling, if applicable.
- A forecast of key intermediate and ultimate yields, as well as the permissible ranges for each
- Packaging details, such as labels, boxes, foils, bottles, and so on
- Precautions, if any, if necessary.
