A MasterFormula Record is defined as an approved master document, with
instructions of how the entire manufacturing process must be performed for each
batch size of each product to be manufactured.
This document ensures that there is uniformity across batches of the same
product.
It gives a complete reliable picture of the manufacturing history of each batch of
every product.
The MFR must be prepared, signed and dated by one competent individual, and
independently checked, signed and dated by another competent person in the
quality department.
3.
All processing ofa given batch must proceed as per its MFR.
MFR shall also be approved for review, changes if any, shall also be
approved by designated person responsible for production and quality
control.
For manufacturing and packaging operations, it is important to have
master production records for each batch size in order to eliminate the
need for recalculation of quantities of components, packaging
materials and in-process samples.
4.
Contents of MFR:
The name of the product, with a product reference code relating to
its specifications
A description of the dosage forms, strength of the product and batch
size.
Name and measure/weight of each active ingredient per dosage unit
or per unit weight or per measure of drug product.
Statement of theoretical weight or measure where necessary in the
processing phase.
5.
Statement of theoreticalyield with minimum and maximum
percentage of yield acceptable beyond which there must be an
investigation of the process.
A statement of the processing location and the principal equipment to
be used.
The methods or reference to the methods, to be used for preparing
and operating the critical equipment e.g. cleaning, assembling,
calibrating, sterilizing, use.
Detailed stepwise processing instructions (e.g. checks on materials,
pre-treatment’s, sequence for adding materials, mixing times,
temperatures)
6.
Procedures forsampling and testing.
Description of containers, closures and packaging materials to be used for the drug
product packing.
Where necessary, the requirements for storage of the products.
Any special precautions to be observed. The master manufacturing records should
also clearly identify :
All manufacturing and control instructions in detail.
7.
Equipment tobe utilized designated by name and where
appropriate, by number.
Special precautions and hazardous conditions that may exist and the
necessary safety equipment to be used.
Space for signature and date of operator/supervisor performing or
checking each significant step
Specimen or copies of each label/labeling material with date and
signature of authorized person who has approved the labeling.
Specifications for raw materials, intermediates and finished
products.
