Topic 3: Product specification and pharmacopiea

Question 1

1. Have an understanding of the purpose of a Product Specification, and the widespread use in a range of industries.

Answer 1

A product specification is a hierarchy of controls within a manufacturing quality applied to ensure the quality of a product.
Specifications are a set of tests and limits which are applied to the product to ensure that every batch is of satisfactory and consistent quality throughout the products shelf life.
Uniquely describe the product so need to describe the label/container etc. And thereby cannot be altered without changing the product specification and its unique identifying number.

Question 2

Structure of a product specification

Answer 2

Has three main elements: Heading information, Body (tests, labelling for product etc) and raw material (primarily the drug substance itself).
Heading: Date, written by, document number, company name, product name
Body: Physical Description, Formula, tests: i.e. uniformity of content, residue on ignition etc

Question 3

interplay between a Product Specification and a Certificate of Assurance

Answer 3

The product specification fully describes the product regardless of batch number or date of manufacture including a description of the tests and limit for product quality. Conversely a batch record describes the results of the tests for each product made