The follow is a brief guideline that companies may use to assist them in becoming a GMP compliant company. These guidelines are not regulation specific, are not all encompassing, and are general in content.
All personnel need to have documented training. Each personnel should have a training file which includes a copy of their CV, a copy of their signature, and copies of all completed training.
A standard format for the CV is a good idea to have. The CV should focus on the employee’s previous experience and education. The employee’s signature log should include their printed name, their signature, their initials, the department they work for, and the current date. Whenever the employee has an official name change or changes departments they should update the signature log. Documented training should be on all operations the employee performs, general company policies and procedures, and on general Current Good Manufacturing Practices (CGMP). It is recommended that training be completed step wise; read procedure, watch the procedure be performed, perform the procedure while be watched, perform the procedure independently. It is recommended that official documented trainers perform the training. Proficiency of the training should be documented. It is recommended that company wide CGMP training be given annually. Consultants should also have a training file that contains their qualifications and details of the services that they are providing to the company.
A standard format for the CV is a good idea to have. The CV should focus on the employee’s previous experience and education.
The employee’s signature log should include their printed name, their signature, their initials, the department they work for, and the current date. Whenever the employee has an official name change or changes departments they should update the signature log.
Documented training should be on all operations the employee performs, general company policies and procedures, and on general Current Good Manufacturing Practices (CGMP).
It is recommended that training be completed step wise; read procedure, watch the procedure be performed, perform the procedure while be watched, perform the procedure independently. It is recommended that official documented trainers perform the training. Proficiency of the training should be documented.
It is recommended that company wide CGMP training be given annually.
Consultants should also have a training file that contains their qualifications and details of the services that they are providing to the company.
An organization chart depicting the reporting structure of the company should be documented and updated on a regular basis. Each position should include a brief job description and the minimum requirements necessary for personnel in that position.
All procedures and policies should be documented. These documents should be available for all personnel to view. The format and content of the documents should be approved by the affected departments (typically documents are signed by three people; the author, the affected department manager, and QA. QA is required to be the last signature on all approved documents). The approved document process should be written into an approved document. This document should include guidelines for format, numbering, look, signature authority, distribution, change, retiring, and filing.
It is recommended that original documents be stored in a secure manner such as locked, fire proof, water proof cabinets. Each area should have document binders that contain only those documents that are relevant to the area and the work being performed in the area. Theses binders should be audited on a regular basis to ensure that only the most current versions are in the binders. There should be at least one area, which is accessible to all personnel, which contain binders with all of the approved documents. It is recommended that the copies in the binders are identified as copies. Such as with a watermark, controlled copy paper, or stamped as copies. There should be documented procedures for coping documents from the document binders. Document content should be reviewed on a regular basis, typically bi-annually, to ensure that it accurately reflects the current processes and procedures.
It is recommended that original documents be stored in a secure manner such as locked, fire proof, water proof cabinets.
Each area should have document binders that contain only those documents that are relevant to the area and the work being performed in the area. Theses binders should be audited on a regular basis to ensure that only the most current versions are in the binders. There should be at least one area, which is accessible to all personnel, which contain binders with all of the approved documents.
It is recommended that the copies in the binders are identified as copies. Such as with a watermark, controlled copy paper, or stamped as copies. There should be documented procedures for coping documents from the document binders.
Document content should be reviewed on a regular basis, typically bi-annually, to ensure that it accurately reflects the current processes and procedures.
An approved procedure detailing the company’s documentation practices should be in place. This procedure should describe practices such as how to correct an error, how to round values, the significant figure rules that are going to be used, the time and date format, and how copies are going to be maintained.
Manufacturing (Mfg) produces the products, Quality Control (QC) tests the products, and Quality Assurance (QA) accepts or rejects the products. The responsibilities of the different departments should be outlined in a Standard Operating Procedure (SOP).
Manufacturing produces products according to approved batch records (BR). Batch records include details of the process, areas for the operator and verifier to initial and date that they have performed the steps, and a review section where the head of Manufacturing and QA sign that they have reviewed and approved the BR. Not every step in BR need to be verified, only critical steps need to have documented verification.
Quality Control tests materials and products according to approved test methods. Test methods outline the testing that is to be performed and include forms for documenting the materials tested, the equipment and materials used to perform the testing, actual results of the testing, and the results of the testing. Test forms should have a signature area for the operator and reviewer. Typically the reviewer is the QC department head. The test results should then be compared to the approved material or product specification to determine if the testing passes or fails. Specifications can be completed by an operator and are reviewed by the heads of both QC and QA.
Personnel health and safety procedures should be put into place. These procedures should outline what protective apparel should be worn in what areas, who is allowed in what areas, how the access to these areas are controlled, and should explain that personnel who are ill are not be allowed into work areas such as cleanrooms and testing facilities.
Cleanrooms should have written procedures explaining what the proper attire to be worn is and what the proper method for gowning is. Personnel should be qualified to gown and periodically monitored to ensure that the proper gowning procedures are being adhered to. Areas that require specific gowning, such as the laboratories, should also have specific procedures for what attire is required in what areas and how to dispose of attire if it becomes contaminated. Health and Hygiene procedures should describe what types of illnesses restrict personnel from working in what areas, for how long, and when they are allowed to return to working in those areas. Procedures need to address specific illnesses such as open lesions, sunburns, allergies, colds, flu, and bacterial infections. Access to the facility and within the facility should be limited to only those personnel who work in the immediate areas. Procedures explaining how access is given, controlled, and maintained should be in place. Such procedures should address the escorting of unauthorized personnel into controlled access areas.
Cleanrooms should have written procedures explaining what the proper attire to be worn is and what the proper method for gowning is. Personnel should be qualified to gown and periodically monitored to ensure that the proper gowning procedures are being adhered to. Areas that require specific gowning, such as the laboratories, should also have specific procedures for what attire is required in what areas and how to dispose of attire if it becomes contaminated.
Health and Hygiene procedures should describe what types of illnesses restrict personnel from working in what areas, for how long, and when they are allowed to return to working in those areas. Procedures need to address specific illnesses such as open lesions, sunburns, allergies, colds, flu, and bacterial infections.
Access to the facility and within the facility should be limited to only those personnel who work in the immediate areas. Procedures explaining how access is given, controlled, and maintained should be in place. Such procedures should address the escorting of unauthorized personnel into controlled access areas.
The majority of equipment should have an equipment logbook in close proximity to the equipment. It is recommended that the logbooks be assembled by QA since they contain copies of controlled and approved forms. Logbooks are to be bound, page numbered, and recommended that they contain separate sections for the different types of assembled forms. The front of the logbook should describe what equipment it is for (via equipment name and number), where the equipment is located (i.e., room number), how many pages of which forms are in the logbook, an unique logbook number assigned by QA and used for tracking of the logbook, and a section o record the completion date and the QA reviewed by. The logbook should include a section for recording the use of the equipment and a section for documenting calibration and maintenance activities. Industry standard is for logbooks to be reviewed on a monthly basis so that any errors that are found can be corrected in a timely manner. After the logbook is completed it is returned to QA for final review and filing; typically it is filed in the equipment files.
Equipment should be maintained and calibrated on a regular schedule.
Specific equipment SOPs should be written describing the frequency of these activities, who is responsible for performing the activities (i.e. in-house personnel or outside service provider), a detailed description of the activities to be performed, how the equipment is to be labeled before, during, and after the activities, and where the activities are documented (i.e. equipment logbook). Each equipment should be labeled with a calibration sticker that tells when it was calibrated, by whom, and when it is next due for calibration. Cleaning of equipment before and after use is generally considered maintenance and should be detailed in the procedure and documented in the logbook.
Specific equipment SOPs should be written describing the frequency of these activities, who is responsible for performing the activities (i.e. in-house personnel or outside service provider), a detailed description of the activities to be performed, how the equipment is to be labeled before, during, and after the activities, and where the activities are documented (i.e. equipment logbook).
Each equipment should be labeled with a calibration sticker that tells when it was calibrated, by whom, and when it is next due for calibration.
Cleaning of equipment before and after use is generally considered maintenance and should be detailed in the procedure and documented in the logbook.
Written procedures for how to receive inspect, store, and release materials need to be in place. The warehouse should contain segregated, limited access, labeled areas for Released, Quarantined, and Rejected materials. These areas should contain appropriate units for storing materials at different temperatures. All materials in those areas should be clearly labeled with their status. Industry standard is to use Red labels for Rejected and Quarantined materials and Green labels for Released materials.
There should be written procedures describing the process that is to be followed when procedures are deviated from. All deviations are documented, reviewed, and if applicable, assigned corrective and/or preventive actions to fix the immediate problem and to ensure that it does not occur again. Product impacting deviations should be investigated to determine what the root cause of the deviation was, what the impact of the deviation is to the product, and to determine of other lots of product are affected. A committee made up of representatives from varies departments (Mfg, QC, QA, R&D) review the product impacting deviations and investigations to determine what the destination of the product (i.e., released for use as is, re-worked, re-tested, discarded, given to R&D, etc.). All aspects of the process are documented. This system is maintained and managed by QA.
The QC department has procedures called Out of Specifications (OOS). Theses procedures are specific to the QC department and are to be used when items that they are testing do not meet the approved specifications. Investigations to determine the root causes of an OOS are handled in the same manner that deviation investigations are handled.
The QC department has procedures called Out of Specifications (OOS). Theses procedures are specific to the QC department and are to be used when items that they are testing do not meet the approved specifications.
Investigations to determine the root causes of an OOS are handled in the same manner that deviation investigations are handled.
