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Product Reference & Its Specification : Master Formulae

The document outlines the key elements that should be included in a master formula for manufacturing products. It states that a formally authorized master formula should exist for each product and batch size made. The master formula should include the name and reference of the product, description of dosage form, strength, batch size, list of starting materials and amounts, expected yield and limits, processing location, principal equipment used, cleaning and assembly methods, detailed processing instructions, in-process controls and limits, storage requirements, and any special precautions.

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273 views

Product Reference & Its Specification : Master Formulae

The document outlines the key elements that should be included in a master formula for manufacturing products. It states that a formally authorized master formula should exist for each product and batch size made. The master formula should include the name and reference of the product, description of dosage form, strength, batch size, list of starting materials and amounts, expected yield and limits, processing location, principal equipment used, cleaning and assembly methods, detailed processing instructions, in-process controls and limits, storage requirements, and any special precautions.

Uploaded by

nutrimake
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Master formulae

 A formally authorized master formula should exist for each product and batch size to be
manufactured.
 The master formula should include:
 Name of the product,
 Product reference & its specification;
 Adescription of the dosage form
 Strength of the product
 Batch size;
 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);
 A statement of the expected final yield with the acceptable limits,
 And of relevant intermediate yields, where applicable;
 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,
i. e.g. Cleaning (especially after a change in product),
ii. assembling,
iii. calibrating,
iv. sterilizing,
v. use;
vi. detailed step-wise processing instructions (e.g. Checks on materials, pretreatments,
sequence for adding materials, mixing times, temperatures);
 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;
 Any special precautions to be observed.

1 PRODUCT NAME: CALCIP TABLET REF. USP


2 specification;

3 DOSAGE FORM: ORAL TABLET


4 STRENGTH OF TABLET CALCIUM 500MG
5 BATCH SIZE: 100,000TABLETS
6 COMPLETE MASTER FORMULATION WITH REF.
7 EXPECTED YEILD WITH LIMITS
8 PROCESSING LOCATION
9 OPERATION OF EQUIPMENTS
10 CLEANING
11 ASSEMBLING

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