(GMP) GOOD MANUFACTURING PRATICES
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
All guidelines follow a few basic principles:
Manufacturing facilities must maintain a clean and hygienic manufacturing area.
Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
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 affect 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.
Cross contamination with unlabelled major allergens is prevented.
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 food or 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 food or drugs minimizes any risk to their quality.
A system is available for recalling any batch from sale or supply.
Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In the United States, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing.
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 fulfil GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
The quality is built into the product and GMP is the most essential part of ensuring this product quality.
Cost: $160 US dollars
Duration:12 (Twelve) contact hours
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Persons interested in the IIFSHL (INTRO TO PEST CONTROL) do not necessarily need to have any previous training to access course.
NOTE: Training is valid for 2 years
in which re-certification will be needed.
The IIFSHL offers 30% off re-certification fees.
Summary of Learning Outcomes
To achieve this qualification, a candidate will learn:
Assessment and Grading
Attainment of the Learning Outcomes will be assessed by IIFSHL international committee members ensuring the candidate has been deemed successful. The examination will consist of forty nine multiple choice questions.
The qualification is graded as either Pass or Fail. Candidates who fail to reach the minimum standard for the Pass grade will be recorded as having failed the assessment and will not receive a certificate.
In order to be awarded a certificate, candidates must be able to recall relevant knowledge and demonstrate a high level of understanding of the principles and concepts used in pest management. Candidates who attain a mark of 75/80 or greater will be deemed to have achieved the criteria for being competent.
Such candidate will be able to satisfactorily work in the industries with the with the knowledge of pest control and its management systems