Chapter 7-GMP and HACCP
Chapter 7-GMP and HACCP
What is GMP?
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use. A
set of principles and procedures which, when followed by manufacturers for therapeutic
goods, helps ensure that the products manufacture will have the required quality.
A basic tenet of GMP is that quality cannot be tested into a batch of product but must be
built into each batch of product during all stages of the manufacturing process.
It is designed to minimize the risks involved in any pharmaceutical production that cannot
be eliminated through testing the final product.
Importance of GMP:
A poor quality medicine may contain toxic substances that was unintentionally
added.
A medicine that contains little or none of the claimed ingredient will not have the
intended therapeutic effect.
10 principles of GMP
1. Design and construct the facilities and equipments properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on instructions
Chapter 5
1. QC is that part of GMP which is concerned with sampling, 1. QA is the sum total of organized arrangements
specifications, testing and within the organization, made with the object of ensuring that product will
documentation and release procedures which ensure that be of the Quality required by their intended use.
the necessary and relevant tests are carried out
2. Operational laboratory techniques and activities used to 2. All those planned or systematic actions necessary to
fulfill the requirement of Quality provide adequate confidence that a product will
satisfy the requirements for quality
3. QC is lab based. 4. QA is company based.
Chapter 5
7 principles of HACCP
1. Identify any hazards that must be prevented, eliminated or reduced to acceptable
level.
2. Identify the critical control point (CCP) at step/steps at which control is essential to
prevent or eliminate hazards or to reduce it atacceptable level.
3. Establish critical limit at CCP that seperate acceptability to an acceptability for
prevent of hazards.
4. Establish and implement effective monitoring procedures at CCP.
5. Establish corrective action when monitoring indicates that CCP is not under control.
6. Establish procedures which shall be carried out regularly to verify that the above
measures are working effectively.
7. Establish documents and records with nature and size of the business to demonstrate
effective applications.
Conclusion:
It confirms accurate monitoring of CCP.
It ensures that HACCP system is adequately controlling food and drug safety hazard.
After initial validation system must be checked regularly.
If HACCP plan do not meet the need modification and revalidation is done.
Contains minimum calibration process that frequently involves direct observation for
monitoring and determine monitoring is done correctly