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Good Manufacturing Practices %28GMP%29

GOOD MANUFACTURING PRACTICES (GMP)

Price : $100

  • 4.75

GMP is Good Manufacturing Practices GMP guidelines help to strengthen the manufacturing process to ensure products are consistently produced and controlled by the quality and safety standards for their intended use and comply the regulatory requirements by health authorities. By implementing GMP at any of food, pharmaceutical and food supply chain such as raw material and packaging suppliers can minimize the risks involved in production process. Currently it is noticed that GMP compliance requirements are rising in other than food and such as pharmaceutical industry and Textile manufacturing units.

GMP covers all aspects of the production process from initial stage material, facility and equipment to the training of personal hygiene of staff. Comprehensively written procedures are essential for each process that could affect the quality of the product. Detailed and effective documented system must be devised to provide documented evidence that correct procedures are consistently followed at each step in the manufacturing process – every time a product made.

It is a voluntary standard therefore it automatically fulfils the expectations of the customers and stakeholders regarding product quality and basic food safety practices.

Certification bodies conducts GMP audits on their own guidelines or checklist and sometimes on auditee’s requirement they refers the guidelines of regulator and country’s standard development authority such as PSQCA, Australian GMP guidelines, Canadian GMP guidelines, European GMP guidelines & US FDA GMP guidelines.

Benefits of GMP Certification

  • Increased customer confidence
  • Control & eliminate the risks that affects final product
  • Ensure sustainable quality system to reduce the errors
  • Ensure safe product use for humans
  • Fulfill the regulatory requirements
  • Prevent mislabeling & adulteration
  • Enhance your brand image
  • Helpful in attracting new customers
  • Helpful to retain the confidence of existing customers

GMP Certification Process

After finalization of agreement with client, experts of Quality Systems visit at client’s premises and conduct the complete gap analysis of existing system against the GMP and discuss the gap report to the management, Identified gaps could be in documents, implementation, employee’s awareness, statutory and regulatory compliances.

We commence work according to the agreed timelines as per final gap report and proceed for the audit once all the documentation, implementation, and other requirements are done. Our technical team provides complete assistance, support and cooperation throughout the process to make certification audit successful in first attempt.

GMP certificate is not awarded once-and-for-all but must be renewed before expiry of the certificate. After applying for the audit to the certification body, they conduct the initial audit. After the successful conduction of audit, certification body issues the certificate of validity of one year till next yearly surveillance audit thus in three years of certification cycle, certification body conducts two surveillance audits with one year of intervals. Basically , audit will be conducted every year in the period of three years. After completion of three years of audit cycle re-audit will be conducted to continue the process of certification.


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Module Quiz

Each course is structured into modules, and at the conclusion of each module, there is a quiz intended to assist students in assessing their grasp of the course material. Once the student submits their quiz responses, they will receive the correct answers for review. Please note that quiz results are not stored and can be retaken multiple times.

Course Exam

Upon completing the course material and module quizzes, students have the opportunity to take the course exam. The course exam is specifically crafted to evaluate the students' comprehension of the course content. These exams consist of multiple-choice questions drawn from our comprehensive question bank.

Exam Characteristics

  • Students are allotted a two-hour timeframe to complete the course exam.
  • To pass the exam, you must attain a minimum score of 70%.
  • If you do not pass the exam, you have the option to retake it.
    • Students are permitted to take an exam a maximum of three (3) times within a 48-hour period.
    • Following the third attempt, students must wait for a 48-hour period before they can make another attempt at the exam. During this interval, it is recommended that students review the course material to enhance their comprehension.
  • After each exam, students will receive an email containing references (module and tab) to the content related to the questions they answered incorrectly. Students are strongly encouraged to review the course material associated with these references to enhance their understanding.
  • If you successfully pass the exam, you are not permitted to retake the exam to improve your score.