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Chapter 7-GMP and HACCP

GMP aims to ensure products are consistently manufactured and controlled to quality standards for their intended use. It builds quality into each batch during manufacturing rather than testing quality in at the end. The key risks GMP aims to minimize are contamination, mislabeling, and insufficient or excessive active ingredients. GMP has 10 principles including designing and constructing facilities properly, following procedures, documenting work, validating processes, and conducting audits. Quality control tests final products while quality assurance ensures products meet quality standards for their intended use through organized arrangements. Hazard analysis and critical control points identifies hazards and critical control points to control hazards at each step of production through seven principles including hazard analysis, determining and monitoring critical control points, establishing limits and corrective actions,

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Farzana Hossain
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133 views5 pages

Chapter 7-GMP and HACCP

GMP aims to ensure products are consistently manufactured and controlled to quality standards for their intended use. It builds quality into each batch during manufacturing rather than testing quality in at the end. The key risks GMP aims to minimize are contamination, mislabeling, and insufficient or excessive active ingredients. GMP has 10 principles including designing and constructing facilities properly, following procedures, documenting work, validating processes, and conducting audits. Quality control tests final products while quality assurance ensures products meet quality standards for their intended use through organized arrangements. Hazard analysis and critical control points identifies hazards and critical control points to control hazards at each step of production through seven principles including hazard analysis, determining and monitoring critical control points, establishing limits and corrective actions,

Uploaded by

Farzana Hossain
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Chapter 5

Good Manufacturing practice (GMP)

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.

Some of the main risks are:


 Unexpected contamination of products which may cause damage to the health of the
recipient or even death.
 Incorrect labels on containers, which could mean that patients receive the wrong
medicine.
 Insufficient or too much active ingredient, resulting in ineffective treatment or
adverse effects.

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

Good Manufacturing practice (GMP)


7. Design, develop and demonstrate job competence.
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits

Quality Control (QC):


QC is that part of GMP which is concerned with sampling, specification & testing,
documentation & release procedures to ensure that the necessary & relevant tests are
performed & the product is released for use only after ascertaining it’s quality.

Quality Assurance (QA):


It is the sum total of the organized arrangements with the objective of ensuring that products
will be of the quality required for their intended use.

Comparison among QC and QA


Quality Control Quality Assurance

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

Good Manufacturing practice (GMP)


Hazard Analysis and Critical Control Point (HACCP):
All operators in pharmaceutical industry are responsible for making sure that the product
produced are safe for consumption i.e. product is not harmful to health. To obtain such
results operators must implement and maintain permanent procedures based on HACCP
principle.

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.

Principle 1: Conduct a Hazardous Analysis


 Hazard analysis is the key to preparing an effectively designed HACCP plan.
 It is important to consider in the hazard analysis the ingredient and raw material,
each step in the process, product storage and distribution and final preparation and
use by consumers.
 A hazard is defined as a biological, chemical/ physical agent that is reasonable likely
to occur and will cause illness or injury in the absence of its control.
 Establishment must be considered all three types of hazard – biological, physical and
chemical at each step of the production process.
 A step is a point or activity in an operation within the production process that is
essential to the proper production of the finished product.
Chapter 5

Good Manufacturing practice (GMP)


Principle 2: Determine Critical Control Points
o The hazard that was analyzed in the hazard analysis must be addressed in the HACCP
Plan.
o Hazard is controlled by one or more critical control point (CCP).
o CCP is defined as “any point, step, procedure in the production at which control can
be applied as a result safety can be attained.
CCP are locations in the process at which control can be applied.

Principle 3: Establish Critical Limits


 The next step in the development of a HACCP plan is to establish critical limits for
each critical control point.
 Critical Limit are the parameter that indicate whether the control measure at the CCP
is in or out of control.
 Control Limit is a maximum/ minimum value to which a biological, physical and
chemical parameter must be controlled at CCP to prevent, eliminate or reduce to an
acceptable level.

Principle 4: Establishing monitoring procedure.


 Once critical limit is set for each CCP during HACCP plan development, Procedures
must be established to monitor CCP and determine whether the control limits are
met.
 Monitoring is the planned sequence of observation or measurements to assure
whether the CCP is under control and to produce accurate record for future
verification.

Principle 5: Establishing Corrective Action


 Specific corrective action depends upon the process used and type of formulation
manufactured.
 Establishing corrective action must be determined at each step or CCP in cases where
Critical Limit is not met.
 When there are deviations from Critical Limit.
 Corrective Action required to prevent potentially hazardous product from reaching
the consumer
Chapter 5

Good Manufacturing practice (GMP)


Principle 6: Establishing Record Keeping And Documentation Process
 When HACCP plan is made it must be ensured that there is effective record keeping.
 Record is written evidence that documents the operation of HACCP.
 All measures taken at Critical control points and any corrective action is been
documented and kept in file.
 If any question arises record is used to trace history of finished product.

Principle 7: Establish Verification Process


Establish verification process is systematically verified.
Four (4) procedures:
1. Scientific and technical process known as validation for determining the CCP and
Critical Limit.
2. Initially and an ongoing bars that the HACCP functions properly.
3. Documented periodic assessment/ reassessment of HACCP plan.
4. Government verification for establishing HACCP functioning properly.

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

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