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BATCH RECORD REVIEW/ RELEASE BY EXCEPTION Mark Wager Eli Lilly August 2015Regulations Regulations specify what must be included in a batch record And What must be reviewed for batch release. Batch

How to fill out batch record

How to fill out a batch record:

1. Start by gathering all the necessary information and materials, such as product specifications, raw material details, equipment used, and standard operating procedures (SOPs).
2. Review the batch record template or form provided by your organization. Familiarize yourself with the various sections and fields that need to be filled out.
3. Begin by entering the batch number and date of production at the top of the record. This will help identify and track the specific batch being processed.
4. Provide a detailed description of the product or formulation being manufactured. Include information such as the ingredients used, their respective quantities, and any specific instructions for their preparation or handling.
5. Record the equipment and machinery used during the manufacturing process. Mention the name, model number, and relevant specifications for each piece of equipment utilized.
6. Document the manufacturing steps taken during the production process. This may include activities such as blending, mixing, heating, cooling, sampling, and testing. Be sure to include time stamps, measurements, and any observations or deviations encountered.
7. If any deviations or unexpected events occur during the production process, make note of them in the record. Mention any corrective actions taken to address these issues, as well as any preventive measures implemented to avoid recurrence.
8. Keep track of the personnel involved in the production process. Record the names, designations, and signatures of the individuals responsible for each step, including quality control personnel who performed required checks.
9. Capture environmental conditions and parameters relevant to the production process, such as temperature, humidity, and pressure. These factors may have an impact on the product's quality and consistency.
10. Once the batch is completed, review the entire record for completeness, accuracy, and compliance with regulatory requirements. Make any necessary corrections or additions.
11. Obtain the necessary approvals and signatures from authorized personnel, such as production supervisors, quality assurance officers, and compliance officers.
12. File the completed batch record in a designated location for future reference and auditing purposes.

Who needs a batch record?

1. Pharmaceutical and healthcare companies that manufacture drugs and medicines require batch records to comply with regulatory guidelines, such as Good Manufacturing Practices (GMP).
2. Food and beverage manufacturers also utilize batch records to ensure consistency and traceability in their production processes.
3. Chemical and cosmetic companies that produce various formulations and products need batch records to maintain quality control and meet industry standards.
4. Contract manufacturing organizations, which manufacture products on behalf of other companies, utilize batch records to maintain accurate records and facilitate label claims and regulatory compliance.
5. Research and development laboratories that perform pilot-scale or small-batch production also require batch records to document their experimentation and data analysis.

In conclusion, filling out a batch record requires careful attention to detail and compliance with applicable regulations. It serves as a vital document, ensuring the consistency, safety, and quality of manufactured products while also facilitating traceability and accountability. Various industries, including pharmaceuticals, food and beverages, chemicals, cosmetics, and contract manufacturing, rely on batch records to meet regulatory requirements and maintain product integrity.

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What is batch record?

Batch record is a document containing details of a specific batch or lot of a product, including manufacturing processes, ingredients, and testing results.

Who is required to file batch record?

Manufacturers and producers are required to file batch record for each batch or lot of their products.

How to fill out batch record?

Batch record is typically filled out by documenting each step of the manufacturing process, including materials used, equipment used, and testing procedures.

What is the purpose of batch record?

The purpose of batch record is to provide a detailed record of the manufacturing process for quality control and regulatory compliance.

What information must be reported on batch record?

Information reported on batch record includes batch number, manufacturing date, expiration date, ingredients used, manufacturing process details, and testing results.