👀 What is the definition of SOP?
SOPs are detailed written
instructions for the operations routinely performed in the course of any activities associated with
pharmaceutical manufacturing.
👀 What are the contents of the SOP?
Objective/Purpose, Scope,
Responsibility, Accountability, Procedure, List of formats/Annexure, Abbreviations,
Reference, Revision History.
👀 Which information should master document carry on every page not just one
of the pages to meet GMP?
Page number, document
reference number and authorizing signatures
👀 How many SOPs required for equipment and what are those?
Operation, Cleaning,
Preventive maintenance/ Calibration, Sampling procedure
👀. What is the Batch production and control record (BPCR)?
BPCR are prepared for each
intermediate and API and include the complete information relating to the completion of
each significant step in the Batch production.
👀. What is the Master production & control record (MPCR)?
To ensure the uniformity from
batch to batch, master production instructions for each intermediate and API are
prepared, dated and signed by one person, immediately checked, dated and signed by a person in the quality unit.
👀. What is Intermediate?
A
material produced during steps of the processing of an API that undergoes further
molecular change or purifications before it become an API.
👀 What is API?
Any
substance or mixture of substances intended to be used in the manufacturing of
a drug (medicinal) product and that when used in the production of a drug,
becomes an API of the drug product. Such substances are intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment or prevention of disease or to affect the structure &
function of the body.
👀 What is Drug substance (API)?
Any substance or mixture of
substances intended to be used in the manufacture of a drug (medicinal) product
and that, when used in the production of a drug, becomes
an active ingredient of the drug product. Such substances are intended to
furnish pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease or to affect the structure and
function of the body.
👀. What is Drug product?
The dosage form in the final immediate packaging
intended for marketing.
👀 How many SOPs are required for equipment?
Operation, Cleaning, Preventive maintenance (or) Calibration,
and Sampling procedure.
👀. What is the BPCR?
BPCR means Batch Production Control Record. This was prepared for each intermediate and API and include the complete information relating to the completion of each step for Batch production.
👀 What is the MPCR? Master production control record (MPCR)?
MPCR means Master Production Control Record. It ensure the uniformity from batch to batch, master production instructions for each intermediate and API are prepared, dated and signed by one person, immediately checked, dated and signed by a person in the quality unit.
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