Preparation of MFR in Pharmaceutical Industry.
What Is MFR?
A Master Formula is required for each batch and batch size. A “batch” or “lot” as defined. in the WHO GMP guideline (TRS 908 Annex 4) is” “batch (or lot) A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous.
EU and PIC GMP guidelines:- “Formally authorised Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. They are often combined in one document.”
Health Canada GMP guidelines:- MASTER FORMULA (formule-type) – A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.
US CFR:- To assure uniformity from batch to batch, master production and
control records for each drug product, including each batch size thereof, shall be
prepared, dated, and signed (full signature, handwritten) by one person and
independently checked, dated, and signed by a second person.master production and control records shall be described in a written procedure and such written procedure shall be followed.
The Master Formula Record should include:
Product Details :-
- the name of the product,
- with a product reference code relating to its specification;
- a description of the dosage form,
- strength of the product
- batch size
- Shelf Life
- Storage Condition
Flow chart :-
- a simple flow chart of manufacturing Process flow should be added In MFR
API/Excipient Details:-
- a list of all starting materials to be used (if applicable, with the INNs),
- with the amount of each, described using the designated name and a reference that is unique to that material (mention should be made of any substance that may disappear in the course of processing);
Equipment:-
- 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 (especially after a change in product),
- assembling,
- calibrating,
- sterilizing,
- use;
Yield:-
- a statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable;
Procedure :-
- Detailed step-wise processing instructions,
- Checks on materials,
- Treatments,
- Sequence for adding materials,
- Mixing times,
- Temperatures
- Blending
- Lubricating
- Compression/filling (Non- Sterile)
In-Process Sampling/ Testing :-
- the instructions for any in-process controls with their limits;
- where necessary,
- the requirements for storage of the products,
- including the container,
- the labelling,
- and any special storage conditions
Packing Process:-
- list of all packing material should be given with Quantity,
- line clearance & storage conditions shall be mentioned
Note:-
- any special precautions to be observed during Trail Batches .
all Above mentioned Details should mention in general Master Formula Record. other Details can be added as per requirements.