GMP Glossary & Definitions

Efficacy:

Measure of the therapeutic effectiveness of a drug.

Electropolishing:

The electrochemical method of removing metal (usually stainless steel) from a surface. More specifically, it is the anodic dissolution of metal in the presence of an electrolyte and an imposed current potential. This process creates a continuous film of chromium rich oxide on the affected surface. The resulting film provides the following benefits:

1. It provides an excellent passive barrier between the body of the material (i.e. internal or external pipe wall) and the contained fluid, or external environment, enhancing corrosion resistance.
2. Provides for improved cleanability and sterilization aspects.
3. Allows for improved quality control by exposing defects in welds and base material.
4. Avoids the surface tension caused when mechanical polishing is used.

Eligibility criteria:

Key facts about a person’s health that make a patient right, or not right, for a certain research study. Examples of these facts include: a person’s age, what symptoms of the illness he or she has, results of certain laboratory tests, a person’s overall health, and past treatments. Both the "must-have" and the "can’t-have" check lists help doctors get clear research results about whom a new drug will help, not help, or harm.

European Medicines Evaluation Agency (EMEA):

The EU licensing authority for pharmaceutical products

Enantiomers:

Compounds with the same molecular formula as the API, which differ in the spatial arrangement of atoms within the molecule and are non-superimposable mirror images.

Ethical drug:

A drug that primarily sold only through physicians and pharmacists, rather through direct selling to customers. Sometimes referred to as a "prescription-only" drug.

European Medicines Evaluation Agency (EMEA):

The EMEA is an agency, which was created for having a centralized licensing of medicinal Products. This includes administering applications for mutual recognition of medicinal products for the European Union member states.

Establish:

Define, document (in writing or electronically), and implement.

Evaluation of Training:

Any attempt to obtain information (feedback) on the effectiveness of a training program and to assess the value of the training in the light of that information.

Evidential Material Coordinator:

A representative of the company who is assigned responsibility for fulfilling evidential material requests made by the Inspector/Investigator as is conveyed them, typically by a Inspection Runner.

Evidential Material List: 

A list used for tracking evidential material submitted to the Inspector/Investigator for review. The list is updated concurrently with material submission. At the completion of the Inspection, the list is printed (if it has been managed electronically), reviewed and filed in the Inspection File.

 

Excipient:

An Excipient is defined as any chemical component other than the Drug Substance / active Pharmaceutical Ingredient (API) in a Dosage Form / Drug product. Examples for excipients are e.g. binders, fillers diluents, disintegrants, lubricants, flavours, colours, and sweeteners.

Expected yield:

The quantity of API or intermediate or the percentage of theoretical yield anticipated at any appropriate phase of production based on data from process development or process validation.

Expiry Date or Expiration Date:

Expiry Date or Expiration Date is defined as the shelf life of products and therefore the date beyond which the product should not longer be used.

or

The date (usually placed on the containers/labels of an API) designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and alter which it should not be used.

Extraneous substance:

An impurity arising from any source extraneous to the manufacturing process.

Export Certificates:

An export certificate is issued by foreign governments to firms. These certificates are applicable for products that are approved or manufactured in one country and exported to another country.

External Audits:

External Audits are defined as audits conducted by external agencies, both government and client companies