What are BMRs & BPRs?

The Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) serve as essential sources of key information in drug production. These records not only capture crucial data related to the processes undertaken but also function as auditable compliance evidence ensuring the accurate manufacturing and safety of human and veterinary medicinal products.

BMRs and BPRs undergo meticulous examination by quality assurance teams to validate the production standards and regulations used, including the timestamp of each activity and the person responsible, creating a concise yet comprehensive overview of the various stages of preparation.

The inclusion of time and personnel details contributes to transparency, accountability, and facilitates traceability, all of which are vital elements in maintaining product quality and safety, and the compliance audit trail for correct manufacture, checked by quality assurance teams.

Click here for European Commission GMP guidelines volume 4 on documentation including BMRs and BPRs.

Batch Manufacturing Record.

The Batch Manufacturing Record (BMR) provides specific detailed instructions and information about the manufacturing processes and procedures required to create the product.

Every BMR must include:

The individual batch numbers.
The composition and unit quantities of the individual materials required to make the product.
The master formula and process used to manufacture the product including composition and weights of materials and components, and specific details like manufacturing equipment settings.

The size and weight of the product.
The storage conditions of the batch.
The start, completion, and expiry date for the products in the batch.
The manufacturer’s license number.

Batch Packaging Record.

The Batch Packaging Record (BPR) provides detailed instructions and information specific to the packaging processes of a batch or a product. It acts as a checklist across the entire manufacturing process to ensure the finished product conforms to specifications and safety requirements.

The Batch Packaging Record should contain:

The name and batch number of the product.
The dates and times of the packaging operations.
Operator identification, denoted by initials, for each key step in the process, along with the names of individuals verifying these operations as applicable.
The documentation of checks ensuring identity and compliance with packaging instructions, inclusive of in-process control outcomes.
Comprehensive details outlining the packaging operations conducted, referencing the specific equipment and packaging lines used.

The inclusion of samples of printed packaging materials when feasible, including batch coding, expiry dating, and any additional overprinting.
The recording and authorization of any unique challenges or unusual events, accompanied by details and the signed approval for any deviations from the Packaging Instructions.
The quantities and reference numbers or identification of all printed packaging materials and bulk product issued, used, destroyed, or returned to stock, along with the quantities of obtained product, to allow systematic reconciliation. Electronic controls used during packaging may validate the omission of this information.
Final approval by the individual responsible for overseeing the packaging operations.

Why choose Aegisana for BMR & BPR support?

Full-service support.

Our GMP Compliance team can provide a comprehensive BMR and BPR creation and review service for all your manufacturing and packaging requirements.

Typical services include but are not limited to:

Procedures for documenting and managing changes to manufacturing or packaging processes, including batch scaling.
Step-by-step procedures for each stage of the manufacturing process.
Specifications and procedures for monitoring and controlling critical points in the manufacturing and packaging processes.
Product labelling instructions including the placement of labels and all required information.
All documentation for audit trail compliance and certification across the entire production process.

Confidence through experience.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your manufacturing site.

Our goal is to provide you with peace of mind and confidence by providing all the documentation and oversight required for complete compliance, safety, and inspection/certification readiness.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the manufacturing and packaging of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.