Finished Product Specification in Pharmaceutical Industry
Finished Product Specification
Fundamentally, a specification is the documented roadmap of how to produce your finished products consistently, legally, and safely.
Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as a condition of approval.
Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure quality and consistency.
Finished Product Specifications are set to make sure safe and quality product is consistently made.
A specification normally comprises of following two types of tests:
Universal Tests
The following tests and acceptance criteria are considered generally applicable to all new drug products.
Description
A qualitative statement about the state (e.g. solid, liquid) and color of the new drug substance.
Examples of product descriptions are
- If the product is a tablet form then we can describe it as ‘A blue coloured elongated, biconvex film-coated tablet having break line on one side & other side plain.
- If the product is in capsule form we can describe ‘Light peach coloured filled capsules with off-white coloured powder.’
- For liquid form, the description can be ‘Light pink coloured flavoured syrup’ etc.
Identification
The purpose of Identification testing is to verify the identity of the active pharmaceutical ingredient (API) on the pharmaceutical product.
The Identification test will be able to discriminate between compounds of nearly related structures that are probably present.
For testing different types of identification methods are used for example HPLC, thin layer chromatography, infrared spectrophotometry, etc.
Assay
An Assay is an analysis used to determine the presence of a particular substance and its concentration.
For example, an assay may be conducted on a vaccine to determine its effectiveness in preventing illness.
Assay by HPLC is the most common chemical test used to measure the quality of the drug substance.
Impurities
Impurity testing is a scientific process of identifying and isolating unknown materials in pharmaceutical finished products.
Several impurity analysis methods are found in pharmaceutical quality control like HPLC/UV method, impurity in the substance is estimated using HPLC techniques by comparing chromatograms from a pair of sample solutions.
Specific Tests
In addition to the universal tests listed above, the following tests may be considered on a case-by-case basis for drug substances and/or drug products.
Different individual tests are performed on drug substances or products to ensure the quality of the product. Some are listed below.
Physicochemical properties
These are properties such as the pH of an aqueous solution, melting point/range, and refractive index.
pH may have a significant influence on drug solubility, stability, and absorption so it is an important factor that can affect it.
For pH testing, a pH meter is used.
Dissolution
Dissolution is the process in which a substance forms a solution.
Dissolution testing measures the extent and rate of solution formation from a dosage form such as a tablet, capsule, etc.
Disintegration
Disintegration measures, under standard conditions, the ability of a sample to break into smaller particles.
a disintegration test is used to show how quickly the tablet breaks down into smaller particles, allowing for a greater surface area and availability of a drug when taken by a patient.
Uniformity of Dosage unit
This test is to analyse the quality control of capsules and tablets.
Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet.
Microbial limit test
This test is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical samples from raw material to finished product.
The test provides information about the tested product by determining if the quantitative limit for certain microorganisms is exceeded.
Water content
Water content or moisture content is a term associated with the amount of water held in a substance or material.
Moisture content determination is an important quality control test in pharmaceutical manufacturing.
The primary methods of water content determination include spectroscopic, chemical, conductivity, and thermogravimetric analysis.
