batch formula record and master formula record

It includes what is batch and master formula record. what should be included in BFR AND MFR, along with the method of preparation of the same.

1. Batch formula record and Master Formula record
Presented by: Rashmita Poojary (19)
Komal Regude(20) T.Y.B.PHARM
➢Masterformularecord:
➢Definition:
Adocumentorsetofdocumentsspecifyingthestartingmaterialswiththeirquantitiesandthepackagingmaterials,togetherwitha
descriptionoftheproceduresandprecautionsrequiredtoproduceaspecificquantityofafinishedproductaswellastheprocessing
instruction,includingthein-processcontrols.
➢Masterproductioninstructionsshouldinclude:
•The name of the intermediate/ API / formulation being manufactures and an identifying document reference code if applicable.
• Complete list of raw material and intermediate.
•An accurate statement of the quality or ratio of each raw material or intermediate to be used, including the unit of measures.
Variation to quantities should be included wherever justified.
•The production location and major production equipment to be used
•Where appropriate, special notations and precautions to be followed, or cross reference to these
•Instructions for the storage of the API or intermediate formulation to assure its suitability for use; instructions should cover the
labelling and packaging material and special storage conditions with time lines.
•Equipment:A list of all required equipment and machines required in the manufacturing process with their capacity.
•Flow chart: Steps of the manufacturing process to be monitored. Flow charts of the material movement from dispensing to the
final product to stores.
•Special instructions: Write down the precautions special instructions to follow during the product manufacturing and packing.
•Calculations: Include the calculation steps of all active materials to get the 100% of the active material.
•Manufacturing Process: Write all the steps in all stages of the manufacturing process including steps like shifting, milling,
mixing, lubricating, granulation, compression and coating should be written in detail including the process time and yield.
•Packing Process: List of all packing materials with their quantity is written.
•Yield:Include the theoretical, actual yield and acceptance limit of the batch.
➢Master formula recordmust
include:
Ranges of
the process
parameters
Sequence
to be
followed
The methods to
be used for
preparing the
critical
equipment's
Sampling
instructions
and in process
control
Time limits
Expected yield
ranges at
appropriate
phases of
process.
Name, address and logo
of the company, Dosage
form, Brand Name,
Generic name, Product
code, Label claim name.
Present Master card
number and Date,
Effective Batch number,
Reference of changed
control number.
Product description:
batch size, pack size, shelf
life, storage conditions,
drug schedule.
Superseded Master card
number and Date.
Superseded Product code
➢Procedure to prepare a Master Formula Record:A Master Formula Record is either prepared based upon experience of
competent qualified staff like manufacturing chemist or analytical chemist or prepared based upon batch manufacturing
record of a batch size. We can’t ignore Master formula record at any level.
➢Steps in preparation of MFR:
•MFR shall be divided into two parts:
1. Packaging part 2. Manufacturing part
➢The first page of both must include:
➢The secondary page of
manufacturing section shall include:
▪Process steps to be monitored.
▪Subsequent pages shall include the
processes to be monitored.
▪The list of equipment, machines,
utensils to be used, shall be described.
▪The subsequent page shall include any
special precautions to be taken for the
product during manufacturing and
packing. The same page should also
include Batch Manufacturing Formula
➢At the end of every important stage, include a statement of the yield with the acceptable limits.
•Include in-process quality checks during and at the end of important steps and stages with their limits.
•The process shall include the process equipment to be used.
•Include detailed stepwise processing instructions (example: checks on materials, pretreatments, sequence for adding materials,
mixing times, temperatures, humidity etc.)
•Include the requirements for storage conditions of the products.
•The packaging part of MFR should include complete list of all the packaging materials required for a standard batch size, including
quantities, sizes and types.
•Include line clearance checking during batch cording and batch packaging operations.
•Include reconciliation of printed and unprinted packaging materials with acceptable limits.
•Include destruction of excess or rejected printed packaging materials.
•Include description of packaging operation including any significant subsidiary operations and equipment’s to be used.
➢Batch Manufacturing record:
➢Definition:
BMR is written document of the batch, prepared during pharmaceutical manufacturing process.
KEYPOINTS
Every batch
has its own
BMR
Actual data and
step by step
process
All stages are
included in BMR
from issuance of
raw material to
finish product.
Documentation
proof are
attached to
BMR during its
production.
BMR contains
all the batch
histoery and
product data .
BPR should be
prepared for
each
intermediate
and API
➢The following information should be recorded in BPR/BMR at the time each action is taken:
•The name of the product, batch number, the quantity of product to be packed, as well as the quantity actually obtained
and its reconciliation.
•The date and time of packaging
•The name of the person responsible
•The initials of the operators
•The checks made for identity and conformity
•The details of packaging operation
•Regular checks
•Notes on any deviation
•The quantities and reference number.
Reference: Quality Assurance-PV book
https://www.pharmaguideline.com/2015/05/batch-manufacturing-record-bmr.html
https://www.pharmaguideline.com/2016/07/preparation-of-mfr-for-pharmaceuticals.html
➢Documentation of completion of each significant step in the BPR should include:
•Date and time
•Identity of major equipment used.
•Specific identification of each batch.
•Recorded result for critical process parameters
•Any sampling performed.
•Signatures of the person performing and supervising critical steps in the operation.
•In process and laboratory test result
•Yield at appropriate phases or time.
•Description of packaging
•Representative Label
•Any deviation, evaluation and investigation conducted.
•Results of release testing
•All analytical records
•Quality control information
•The product record review.
Permanent
Signed
LegibleAccurate
Original
The Ideal BMR
must be: