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AskaboutValidation is pleased to announce the creation of our brand new GAMP 5 forum. Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.

Good Manufacturing Practices

More specifically, the ISPE’s guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process.

As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
A group of pharmaceutical professionals have banded together to create the GAMP Forum, which is now a technical sub-committee, known as the GAMP COP (community of practice) of the International Society for Pharmaceutical Engineering (ISPE). The goal of the community is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry.

The GAMP COP organizes discussion forums for its members. ISPE organises GAMP-related training courses and educational seminars. Several local GAMP COPs, such as GAMP Americas, GAMP Nordic, GAMP DACH (Germany, Austria, Switzerland), GAMP Francophone, GAMP Italiano, GAMP Benelux (Belgium, Netherlands, Luxembourg) and GAMP Japan bring the GAMP community closer to its members in collaboration with ISPE’s local affiliates in these regions.

GAMP Guidance

ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP5) was released in February 2008.[2]

Other publications in the GAMP series include:

  • GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
  • GAMP Good Practice Guide: Calibration Management
  • GAMP Good Practice Guide: Electronic Data Archiving
  • GAMP Good Practice Guide: Global Information Systems Control and Compliance
  • GAMP Good Practice Guide: IT Infrastructure Control and Compliance
  • GAMP Good Practice Guide: Testing of GxP Systems
  • GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
  • GAMP Good Practice Guide: Validation of Process Control Systems

Check Out Our New Forum

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Training of personnel on deviation reporting and deviation handling is essential to a successful implementation of deviation management. All personnel must have a clear understanding of the deviation concept on all level of operation.

From a cleaning employee to a top level manager, everyone in the organization must apply deviation management procedure or instructions.

In order to do that, it must be mandated that all employee will attend at least once per year training on how to identify and report deviations.

 

The Three Levels

It is important to keep record of all the training’s performed in order to demonstrate to auditors that all personnel in the organization are competent and can report, handle, and/or manage deviations in a swift and accurate manner.

There are three levels of training on deviation management:

  1. Level 1: Identifying deviations and reporting them
  2. Level 2: Deviation Handling and Investigating
  3. Level 3: Deviation’s Corrective and Preventive Action

Level 1: Identifying Deviations and Reporting Them

  • This level of training should be mandated for all employees.
  • In this level, the trainee must learn how to notice and identify a course of actions or results which might indicate that something deviated from the standard and approved procedures in the quality management system.
  • This particular skill is crucial to the deviation reporting.
  • The trainer must spend considerable time developing attention to details in trainees. This particular competency forms the basis on which the trainer will build the trainees knowledge of deviation management.
  • The second obstacle to overcome is to make the employees understand that deviation reporting isn’t the equivalent of mistakes reporting.
  • In my experience, at first, many employees will see deviations as a way for the top management to record their mistakes for performance evaluation and bonus estimation.
  • The trainer must explain that it is the opposite of that concept, deviation reporting is your chance to express your interest in preserving the quality of the product or the service you provide in your organization.
  • It asserts your loyalty to the a quality based product and/or service and your devotion to the company’s standards.
  • Level 2: Deviation Handling and Investigating

    • This level of training is exclusive for management staff, including both lower and upper management.
    • In this level of training, the trainer must focus on investigational techniques and root cause analysis.
    • The basis of the training is risk analysis. The trainer must be an expert in risk identification, assessment, evaluation, reduction, and communication.
    • Other essential techniques include listening skills, communication, team work, and meeting management. These skills must be honed by the trainees during the training and during normal working hours.
    • The trainer must emphasis that this level of training is a mere introduction into deviation handling and that practice makes perfect. The reason is no one can develop all the skills necessary for investigating and solving complex deviations in one training module. The experience of the person practicing those tasks is the ammunition that would help him or her succeed at his or her job.

    Level 3: Deviation’s Corrective and Preventive Action

    • This level of training is exclusive to quality assurance personnel and upper management (including other department’s managers).
    • The aim of this training is to develop the ability of trainees to find the most efficient and effective actions to correct and prevent the deviation from reoccurring.
    • As we mentioned in 3.1.8. there are several points to consider when taking corrective and preventive actions. These points must be included in the training.
    • The trainer can be someone with experience with the applied procedure for corrective and preventive action in the organization and it would be better if he or she is experienced in risk management as mentioned in level 2 training.
    • If the training is being conducted for the first or second time, the trainer must emphasis to upper management that the trainee will need time to develop the experience necessary for them to create systematic actions with little to no side effects.
    • This training must conclude that the personnel required to decide the corrective and preventive actions must convene periodically in order to discuss the effectiveness of their actions and see what they can improve in their decision approach.

    Optional Training Sessions

    There are several competencies which are essential to successful deviation management, time management is one, communication management is also an essential feature which is greatly needed for the continuous and effective follow-up of deviations throughout the organization.

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Not all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability.

Choosing a Vendor

The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.

Regulated Environment

When working in a regulated environment one of the key questions that needs to be considered is will the product of service affect your product quality. If the answer is yes then it is paramount that you can trust your supplier/vendor and the quality of their product or service

Supplier Qualification Online Course

This module is taken from our course on Supplier Qualification.

 

About Us

Learnaboutgmp is a cloud based learning management system (LMS) designed specifically for life science and regulatory organizations. Our LMS contains the courses you need to help you achieve regulatory compliance. With new courses published every month and existing courses updated in line with regulatory changes we are your true continuous learning platform.

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