Good Manufacturing Practice (GMP)

GMP: Good Manufacturing Practice is that part of Quality Assurance which insure that products are consistently produced and controlled the quality, standards appropriate to their intended use and required by the marketing authorization or product specification. Good manufacturing practice (GMP) could ...

Standard Operating Procedure (SOP)

S.O.P.: A written authorized procedure that gives instruction for performing operation not necessary specific to a given product or materials, but of amore general nature (e.g. Equipment operation, maintenance and cleaning, cleaning of premises and environmental control, sampling and inspection, etc) ...

Method Validation

Method Validation: Method validation is the process used to confirm the analytical procedure employed for the specific test is suitable its intended uses. Method Validation is a crucial analytical tool to confirm the accuracy and specificity of the analytical procedures with a certain agreement. This ...

Master Formula

Master Formula: Documents used in pharmaceutical manufacturing generally containing the name, description, strength of a product, batch size, a complete test of ingredients, quantities of ingredients, specification of each ingredients used in product, theoretical yield, manufacturing and control instruction, ...

Stability study

Stability study: It is the study to determine the self-life of a product how much time the product remain stable in the market and confirm with product specification meet the pharmacopoeia limit. Stability testing is integral to developing new pharmaceutical merchandise and active pharmaceutical ingredients, ...

Specification

Specification: A document giving a description of a starting material, packing material, intermediate bulk or finished product in terms of its chemical, physical and biological characteristics. The International Conference on Harmonization (ICH) defines specifications as “a list of tests, references ...

In process control

In process control: Tests, Cheeks and measurements made during the course of manufacture that result and product will comply with its specification. In-Process Control refers to the checks performed during production in order to monitor and if necessary to adjust the process and/or to ensure that the ...

Compliance

Pharmaceutical compliance is the processes and activities undertaken by a pharmaceutical company to ensure that its products meet all applicable regulatory requirements. This includes ensuring that products are manufactured, distributed and marketed in compliance with Good Manufacturing Practices (GMPs), ...

Medicine

Medicines or drugs are chemical substances which, when applied, affect the normal functions of the body and by which diseases are destroyed or cured, or pains and sufferings are alleviated; Includes herbal remedies. Medicines are basically of two types: therapeutic (curative) and prophylactic. According ...

Pharmaceutical industry

The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceuticals for use as medications to be administered to patients (or self-administered), with the aim to mitigate symptoms or disease conditions, vaccinate them, or alleviate symptoms of disease or surgical or disease ...
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