Consistency is most important aspect for any manufacturing procedure. We need similar product in every batch at every time we manufacture it. It should be difficult to find out any difference of a product processed in two different batches. For building consistency in the process, master formula record plays an important role. Master Formula Record can be prepared electronically or manually but a hard copy of master formula record should be present during manufacturing process.
How can we define master formula record?
A record of name of product, manufacturing procedure, ingredients/composition of product and their specifications, machinery used, batch size, dosage form, intermediate/final yield, storage conditions, step wise processing instruction etc and other related things for maintaining consisting of each and every batch. It is used as reference standard for manufacturing procedure.
A master formula record is prepared and endorsed by the competent technical staff like manufacturing chemist and analytical chemist etc. There should be master formula record related to all manufacturing procedures for each product and batch size to be manufactured. A master formula record should contain a complete description or reference code for understanding standard process.
Contents of Master Formula Records:
- The Name of Product together with product reference code relating to specifications
- Description of dosage form, strength, composition of product and batch size
- Patent, proprietary name of the product along with Generic Name of product and its ingredients along with excipients used
- Special mention of the substance that may disappear during manufacturing process
- Specifications and reference code of each and every ingredients/excipient used in manufacturing procedure
- Location and Machinery used in process, and their specifications including cleaning, assembling, calibrating, sterilizing, operating procedure etc
- Stepwise detailed processing instructions and time taken by each and every step
- Instruction related to in-process control i.e. quality checks, samples taken, test to be conducted etc
- Requirements for storage and processing conditions of the product including container, labeling and special storage conditions if any
- A statement regarding expected relevant intermediate and final yield with the acceptable limits
- Packaging material details i.e. labels, boxes, foils, bottles etc
- Any special precaution and instructions if any
Procedure to prepare a Master Formula Record:
We can’t ignore Master formula record at any level. Once Master Formula Record is prepared, it is transferred to previous staff to new staff. It is followed as standard documents for processing a batch. Master Formula record is consider as standard for making a Batch Manufacturing Record