Easy Learning ICH Q7-Part 1

The series is to comprehend Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients-ICH Q7

Total Section/Chapters are 20 where 1st and 20th Chapters are Introduction and Glossary

Pharma Terminology-Easy Learning

General Terminology of Pharma

1. Active Pharmaceutical Ingredient (API) and Excipient:

A drug comprises of two portions: API and Excipient. An excipient is the inert portion of the drug whereas API is the chemically active portion. Chemically active portion refers to the part of the drug which created the desired effect in the body.

2. Change Control:

The systematic approach to managing all changes made to a product or systems. The purpose is that all changes identified, reviewed, approved, archived and very well evaluated.

3. Raw material:

A raw material refers to a starting material, reagents, processing aids or solvents that are used to manufacture an API or an intermediate.

4. Impurity:

Any undesired entity present in any component of an API or Intermediate.

5. Intermediate:

An intermediate is a material that is produced during the manufacturing of API that undergoes further molecular change or processing to become an API. This is to be noted that as the intermediate is produced during the manufacturing of an API, the manufacturer shall decide the point where the initiation of API takes place.

5. Manufacturing:

Manufacturing in ICH refers to all the operation including receipt of material, production, packaging, repackaging, labeling, relabeling, storage, dispatch. It also quality control, release and all the other related control.  

6. Sampling:

Sampling is a technique in which a predefined quantity is taken from the whole lot for the purpose of analysis.The result of the analysis decides the fate of the whole lot.

The GMP Systems (General Requirement)

Every pharmaceutical manufacturer is responsible for establishing a GMP system in his manufacturing industry. In order to maintain an established framework of GMP system in theThe most essential requirements for maintaining good manufacturing practices in pharmaceutical industries is to have a strong system for

• Personnel
• Premises 
• Equipment
• Standard operating procedures 

Menthol Crystals-MSDS

1.        Product Identification

Product Name	Menthol Crystal Levo Natural
CAS No.	2216-51-5
EINEC No.	218-690-9
Molecular Weight	156.3 g/mole
Molecular Formula	C10H20O
Other Name	Menthol Crystal, Levo Menthol
Recommended Use	Flavouring substances, food additives
Pharmacopoeia	USP, EP, BP, JP, IP

Data Integrity-PART A

The data integrity has turned into an intense issue which is bringing association a terrible name during regulatory inspection. The administrative body trusts that the organisation where the information is precise, reliable and accurate and follow the regulatory guidelines and SOPs are working legitimately.

Management Reviews

To bring coherence in organisational functioning as also to determine operational performance, the top management of the company reviews the system performance regularly discussing all relevant issues so as to achieve performance improvement. A system of internal communication has also been established.

SOP ON REPROCESSING

1. OBJECTIVE

To describe the procedure for reprocessing of intermediate or API, which does not confirm to the standards or specifications.