master formula regulatory affairs

1. MASTER FORMULA RECORD
 PRESENTEDBY:
 KARTHIK SWAMY B.M
 DEPARTMENT OF
PHARMACEUTICS
 V.L COLLEGE OF
PHARMACY RAICHUR

2. Master formula Record:
“A document or set of documents
specifying the starting materials with their
quantities and packaging materials,
together with a description of the
procedures and precautions required to
produce a specific quantity of finished
product as well as the processing
instructions, including the in process
controls”.
• Master formula record is prepared to
achieve uniformity within batch to batch.

3. Role of Master formula Record (MFR) according to the
guidelines from different countries:
 European Guidelines: MFR is not only for every batch
but it includes manufacturing formula and instructions to
be maintained for each product that to be manufactured in
one document.
Canadian Guidelines: MFR is set of documents
specifying the raw materials with quantities and packaging
materials with detailed descriptions of manufacturing
procedures and precautions required to produce the
specified quantity.
US Guidelines: MFR is written to ensure uniformity from
batch to batch and consists of master production control
for each batch size where as it should be dated and signed
by one, again dated, signed and checked by another

4. The master Formula shall include:
(a) the name of the product together with product
reference code relating to its specifications;
(b) the patent or proprietary name of the product along
with the generic name, a description of the dosage form,
strength, composition of the product and batch size
(c) a statement of the processing location and the principal
equipment to be used.
(d) name, quantity, and reference number of all the starting
materials to be used. Mention shall be made of any
substance that may .disappear. in the courts of processing.
(e) a statement of the expected final yield with the
acceptable limits, and of relevant intermediate yields,

5. (f) The methods, or reference to the methods, to be us
ed for preparing the critical equipments including cle
aning, assembling, calibrating, sterilizing.
(g) detailed stepwise processing instructions and the time ta
ken for each step;
(h) the instructions for in-process control with their limits
(i) the requirements for storage conditions of the products, in
cluding the container, labeling and special storage conditions
where applicable;
(j) any special precautions to be observed; and
(k) packing details and specimen labels.

6. 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. Once Master Formula Record is prepared, it
is transferred to previous staff to new staff. It is
followed as standard documents for processing a
batch. Master Formula record is consider as
standard for making a Batch Manufacturing
Record.

8. THANK
YOU