CGMP Flashcards
Part 1 of CGMP
General Provisions
Section 1 of Part 1
Authority
Section 2 of Part 1
Statement of Policies
Section 3 of Part 1
Statement of Objective
Statement 4 of Part 1
Definition of terms
Nearest value obtained
Accuracy
Quantity that is actually produced at any phase of production
Actual yield
An enclosed space with two or more door.
Airlock
Pass through hatch
Anteroom
Airlock
Quantity of product that is homogenous in character
Batch
A designation in numbers or letters or combination thereof that identifies the batch
Batch number
Contained system such as Fermenter
Biogenerator
Container used to store liquified gas
Cryogenic vessel
System of Quality assurance
GMP
Culture of fully characterized cell
Master cell bank
Culture of microorganisms distributed from single bulk
Master seed lot
System where successive batches of product are derived from same master
Seed lot system
Unit of Blood
Unit
Sections of Part 2: 1-7
1 - Personnel
2 - Premises
3 - Equipment
4 - Sanitation and Hygiene
5 - Storage of starting material and finished product
6 - production
7 - QC
Set of principles.intended to assure quality and integrity of non-clinical laboratory studies
Good laboratory practice
Purpose of GLP
Assure quality and integrity of data submitted
Certify every step of analysis is valid or not
Emphasis data recording
3 types of inspection
Study-based inspection
Facility-based inspection
Process-based inspection
Evaluate whether the company’s operation remain compliant with GMP
Self inspection
Daily or Intermediate correction
Self-inspection Informal
Quarterly - Improved system
Self-inspection Formal
Yearly - Confirm compliance
Quality control - Internal
The quantity that is expected or planned to be obtained at any phase of
production of a particular product, based on the quantity of components to be
used.
Theoretical yield
