Batch Formula Record & Master Formula Record
A Batch Formula Record (BFR) is a document used in the manufacturing of pharmaceutical products to
record the specific formulation and manufacturing instructions for a particular batch or lot. It serves as a
comprehensive record of the ingredients, quantities, and processing steps involved in the production of
the batch. The BFR is an essential part of good manufacturing practices (GMP) and ensures consistency,
traceability, and quality control throughout the manufacturing process.
The following information is typically included in a Batch Formula Record:
1. Product Information:
Name of the product
Batch or lot number
Manufacturing date
Expiry date
Packaging details (e.g., container type, size, and closure)
2. Formulation:
List of all ingredients, including active pharmaceutical ingredients (APIs), excipients, and
any other components used
Accurate and complete description of each ingredient, specifying the grade, source, and
supplier
Quantities or percentages of each ingredient
Detailed instructions for weighing or measuring each ingredient
3. Manufacturing Instructions:
Step-by-step instructions for the manufacturing process, including equipment used,
operating conditions, and processing times
Specific instructions for mixing, blending, granulation, compression, coating, and any
other relevant manufacturing steps
Parameters to monitor during the process (e.g., temperature, humidity, pH)
In-process control tests or checks at various stages of production
Packaging instructions, including labeling requirements and packaging materials
4. Quality Control:
Specifications and acceptance criteria for raw materials, intermediate products, and
finished products
Sampling procedures and testing methods for quality control purposes
Test results and analytical data, including identity, purity, potency, and any other relevant
quality attributes
Reference to relevant standard operating procedures (SOPs) or analytical methods used
for testing
5. Batch Records and Documentation:
Cross-references to other relevant batch records, such as equipment cleaning records,
equipment calibration records, and environmental monitoring records
Documentation of deviations, incidents, or changes made during the manufacturing
process
Signatures and dates of personnel involved in the production, quality control, and quality
assurance activities
Any additional comments or observations related to the batch
It is essential to maintain accurate and up-to-date Batch Formula Records throughout the manufacturing
process. These records serve as a reference for reproducibility, troubleshooting, and quality investigations.
They are subject to review by regulatory authorities during inspections and audits to ensure compliance
with GMP guidelines and to verify the safety, efficacy, and quality of the manufactured pharmaceutical
products.
Master Formula Record
A Master Formula Record (MFR) is a document used in the pharmaceutical industry to provide detailed
instructions and specifications for the production of a specific pharmaceutical product. The MFR serves
as a comprehensive reference for manufacturing personnel and ensures consistency, accuracy, and quality
control in the production process.
The following information is typically included in a Master Formula Record:
1. Product Information:
Name of the product
Product code or reference number
Description and dosage form (e.g., tablet, capsule, liquid)
Strength or concentration of the active ingredient(s)
Batch size or manufacturing scale
2. Formulation:
List of all ingredients, including active pharmaceutical ingredients (APIs), excipients, and
any other components used
Accurate and complete description of each ingredient, specifying the grade, source, and
supplier
Quantities or percentages of each ingredient
Detailed instructions for weighing or measuring each ingredient
Compatibility and incompatibility information for the formulation components
3. Manufacturing Instructions:
Step-by-step instructions for the manufacturing process, including equipment used,
operating conditions, and processing times
Specific instructions for each manufacturing step, such as mixing, granulation, blending,
compression, coating, and packaging
Parameters to monitor during the process (e.g., temperature, humidity, pressure)
In-process controls and tests to be performed at various stages of production
Instructions for the addition of excipients, processing aids, or other substances during
manufacturing
Packaging instructions, including labeling requirements, packaging materials, and special
handling instructions
4. Quality Control:
Specifications and acceptance criteria for raw materials, intermediate products, and
finished products
Sampling procedures and testing methods for quality control purposes
Test parameters and limits for identity, purity, potency, dissolution, disintegration, and
any other relevant quality attributes
Reference to relevant standard operating procedures (SOPs) or analytical methods used
for testing
Requirements for stability testing, including storage conditions and testing time points
5. Storage and Stability:
Recommended storage conditions for raw materials, intermediates, and finished products
Shelf-life or expiration date of the final product
Special storage considerations (e.g., temperature, humidity, light protection)
6. Change Control and Version Control:
Procedures for updating and revising the MFR, including change control processes
Document control information, such as version number, effective date, and revision
history
Approval signatures and dates of personnel responsible for approving and reviewing the
MFR
The MFR serves as a master document and is used as a reference for creating batch-specific documents,
such as Batch Formula Records (BFRs), which contain specific instructions and records for each
manufacturing batch. The MFR provides a standardized and controlled approach to pharmaceutical
manufacturing, ensuring product consistency, quality, and compliance with regulatory requirements. It is
subject to review by regulatory authorities during inspections and audits.
