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Good Manufacturing Practice
Good Manufacturing Practice
Although there are a number of them, all guidelines follow a few basic principles.
• Manufacturing processes are clearly defined and controlled. All critical processes are
validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated.
Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous language. (Good
Documentation Practices)
• Operators are trained to carry out and document procedures.
• Records are made, manually or by instruments, during manufacture that demonstrate
that all the steps required by the defined procedures and instructions were in fact
taken and that the quantity and quality of the drug was as expected. Deviations are
investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a
batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the drugs minimizes any risk to their quality.
• A system is available for recalling any batch of drug from sale or supply.
• Complaints about marketed drugs are examined, the causes of quality defects are
investigated, and appropriate measures are taken with respect to the defective drugs
and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a
series of general principles that must be observed during manufacturing. When a company is
setting up its quality program and manufacturing process, there may be many ways it can
fulfill GMP requirements. It is the company's responsibility to determine the most effective
and efficient quality process.
Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics
and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices, differs
from traditional "produce and test" quality control methods which are less successful and
inappropriate for highly perishable foods. In the US, HACCP compliance is regulated by 21
CFR part 120 and 123. Similarly, FAO/WHO published a guideline for all governments to
handle the issue in small and less developed food businesses.[3]
Principle 2: Identify critical control points. A Critical Control Point (CCP) is a point, step,
or procedure in a food manufacturing process at which control can be applied and, as a result,
a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.
Principle 3: Establish critical limits for each critical control point. A critical limit is the
maximum or minimum value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.
Principle 5: Establish corrective actions. These are actions to be taken when monitoring
indicates a deviation from an established critical limit. The final rule requires a plant's
HACCP plan to identify the corrective actions to be taken if a critical limit is not met.
Corrective actions are intended to ensure that no product injurious to health or otherwise
adulterated as a result of the deviation enters commerce.
Principle 6: Establish record keeping procedures. The HACCP regulation requires that all
plants maintain certain documents, including its hazard analysis and written HACCP plan,
and records documenting the monitoring of critical control points, critical limits, verification
activities, and the handling of processing deviations.
Verification ensures the HACCP plan is adequate, that is, working as intended. Verification
procedures may include such activities as review of HACCP plans, CCP records, critical
limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include
verification tasks to be performed by plant personnel. Verification tasks would also be
performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as
one of several verification activities. Verification also includes 'validation' - the process of
finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical
limitations).
[edit] Standards
The seven HACCP principles are included in the international system ISO 22000. This
standard is a complete food safety management system incorporating the elements of
prerequisite programmes for food safety, HACCP and quality management system which
together form an organization’s Total Quality Management.