Query:
What is batch no and what contain in batch record and how to maintain it please answer. In details with example.
Response:
What is Batch Number?
Batch Number is a serial number used to identify the manufacturing processing of a products batch details like date and time of each and every manufacturing process, quality standard of raw material used, detail of competent staff and works present during manufacturing procedure, machinery used during manufacturing process etc. In other words, we can say a batch number is a number given to record which contains all details related to manufacturing and quality procedure of a particular batch and lot.
What is Batch Manufacturing Record (BMR):
There should be detailed and complete manufacturing process record maintenance of a batch. It differs from Master Formula Record. Each and every batch processing record should be maintained, signed and checked by authorized persons.
Batch Manufacturing Record may be defined as a document which contains complete process detail , and all reports,records and statements related to manufacturing process of a particular batch and lot.
Contents of Batch Manufacturing Record:
- Serial Number of Batch Manufacturing Record
- Brand Name of the Product
- Generic Name of all ingredients
- Batch Number/Lot Number
- Batch Size/Lot Size
- Date of Manufacturing and Date of Expiry
- Maximum Retail Price
- Master Formula Record Reference detail
- Date of commencement of Manufacturing and Date of Completion of Manufacturing Process
- Date and time of Each Step of process of manufacturing with signature and name of persons present during manufacturing and analytical processes
- Name of all competent staff and operators carrying out different activities
- Name of all ingredients used for batch manufacturing along with quantity
- Grade and quality of all ingredients checked by quality control department
- Control Reference number of all ingredients
- Time taken by Each and every step involved in manufacturing process like blending, mixing etc
- Quality Assurance Standards and environmental activity records whenever applicable like pH of solutions, filter integrity testing, temperature and humidity etc
- Date and Time of Test Sample taken & results of each test conducted during manufacturing process and after manufacturing process like weight, leak test, hardness test, fragility test etc whenever applicable
- Inspection Records
- Machinery, Equipment and other applicable things washing record
- Theoretical yield, Permissible yield, actual yield and variation record along with clarification if any
- Reference number of relevant analytical reports
- Details of reprocessing if any
- Packaging material details and specimen of printed packaging material
How to maintain Batch Manufacturing Record (BMR)?
A BMR is maintained and filled during manufacturing process. It has started to fill and maintain before manufacturing process and continue till after completion of manufacturing process.
Important Things to Maintain in Production Manufacturing Record:
- General requirements
- Equipment cleaning and use log
- Component, drug product container, closure, and labeling records
- Master production and control records
- Batch production and control records
- Production record review
- Laboratory records
- Distribution records
- Complaint files.
Hope this information will be helpful to you… For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com