Study Set Content:
provide guidelines to develop systems which ensure that manufacturing facilities and processes are properly designed, monitored and controlled
Current Good Manufacturing Practices (cGMP)
CGMP Inspection Coverage Examples
- Actual conditions and practices
- Raw Material Quality
- State of maintenance of equipment, and facilities
- Personnel -- Actual Operations, Procedures, Training
- Changes in manufacturing and laboratory
- Adequacy of design (discussed 18x in CGMP regulations)
- Latest stability data
- Process Implementation and experience
- Process Validation, lifecycle improvements
- Batch trends: latest in-process control data
- Complaints, returns, deviations, failures, OOS and
- is the activity of monitoring and controlling any particular production or operation
Production control
is one of the key functions of operations management
Production control
Four important documents used in production control
- Manufacturing monographs
- Quality control monographs
- Batch records
- Standard operating procedures
master formula and batch production records are based
Manufacturing monograph
contains the quality of each component used in manufacturing and assuring that they had been tested and met the specifications in accordance with the standards.
Quality control monograph
are generated to explain in detail the reason behind a procedure and proper sequence of steps to be done, and how an equipment is operated.
Standard operating procedures
An accurate reproduction of the master formula record.
Batch production record
It permits the reconstruction of the history of the product, manufacturing procedures, production records, packaging records, raw material record
Batch production record
is required to assure product safety, identity, purity, quality and strength.
Control testing
Different control testing is conducted for the following:
- solid preparation
- Liquid preparation
- semi-solid preparation
- lyophilized preparations
- aerosols preparations
used as key in the production of the products.
Master Formula
- it is kept in a secured documentation room
Master formula
A specific amount produced in a unit time or according to a single manufacturing order during the same cycle of manufacture
Batch
A batch, a portion of a batch or a combination of batches
Lot
Any distinctive combination of marking, letters, or numbers by which a history of the manufacture and control of a batch of product can be determined
Batch numbers
A date of retest to revalidate the material and product.
Re assay dates
Based on the stability of the raw materials the re assay dates are: 6 months
vitamins, flavors
Based on the stability of the raw materials the re assay dates are: 12 months
active ingredients, dyes
