More than 40 pages in length, this self-explanatory PAI protocol for API guides you through the entire PAI preparation process. Similar to the PAI Protocol for DPs, it focuses solely on the specific circumstances of API producers.Show all details
More than 40 pages in length, this self-explanatory PAI protocol for drug products guides you through the entire PAI preparation process. It was created to systematically identify the strengths, opportunities, weaknesses and threats associated with organisation, personnel, qu Show all details
This ready-to-use 21 CFR 820 quality audit questionnaire (audit by mail) has been created for the assessment of potential device suppliers that need to comply with the US FDA regulatory requirements set out in 21 CFR 820. The checklist will help you evaluate potential supplie Show all details
This checklist will enable you to systematically assess the strengths and weaknesses of a computerised system validation using a uniform approach. A scoring option is included which enables you to compare different systems and helps you to judge the compliance status of these Show all details
The systematic inspection of a manufacturing facility requires a comprehensive GMP knowledge. One important tool is a checklist to ensure that the auditor doesn’t miss anything necessary to be looked into. The checklist might also act as a reminder of GMP guidelines. Failure to comply with the GMP regulations might compel FDA to consider your drug adulterated. You should be aware that also FDA investigators (inspectors, auditors) use checklist. Typical points on these checklists are as follows:
This part of a GMP checklist ensures if the fundamental things are in place at your site. The visiting FDA investigator will check if:
- The company is ISO certified (if applicable and relevant)
- Result and follow up of previous Audits
- A well-maintained quality control laboratory with enough facility, employees and equipment to perform the physical, chemical and microbiological testing
- Everything is well documented. If something is not documented then it is not done, they might not really consider whether the event has really occurred or not
- Responsibility of every person is clearly defined in their job descriptions
- Regular evaluation of records to determine the quality standards and highlight the changes
- f the company maintains all the records related to manufacturing, control and distribution at least until the product expires
FDA requires the premises to be safe and well-maintained to produce quality drugs. The GMP checklist for inspection of premises looks into:
Design & Layout
Is your company properly designed to have separately defined space for manufacturing operations? Does the layout of the manufacturing facility support proper ventilation, light, drainage, humidity, temperature and pressure? The investigator also has to mark on the checklist whether the facility has an emergency power supply to meet the urgent energy demands.
Safety & Security of Facility
You have to have an effective safety program with following written procedures. The access to manufacturing plant should be restricted to employees only and an outsider should only be allowed if he doesn’t pose any threat to safety and security measures.
The broad spectrum of checklist covers fire control measures, emergency exit and availability of safety clothing. Ensure that the company also has a sanitation program to prevent contaminants and micro-organisms from harming the facility, processes and staff.
There should be sufficient number of qualified, trained and experienced staff to carry out all the operations in a coordinated manner. Do provide an organization chart in the facility to clearly demonstrate the responsibilities of each department. Ensure that each staff member has undergone a health check-up and they are not suffering from any contaminating disease.
Validation is an important part of the GMP checklist. The production procedures have to be qualified. The master formula and steps of preparation should demonstrate that they produce desired product every time.
The documentation of Validation Reports, Validation Protocols and Validation Master Plan is another key aspect. All these documents and procedures should be qualified.
The checklist has the following points regarding process records:
- Type and purity of the starting material
- Specifications about the intermediaries produced
- Detailed steps for process operation
- Records for packaging and labeling operations
- Standard Operating Procedures for every task
- Log books for complex and major equipment
- Environmental monitoring
- Complaints and product recalls
- Stability studies based on SOP to test the stability of finished products
The facts added in the GMP checklist about manufacturing area are centered on equipment, components and raw materials. The investigator will check if your company has suitable equipment that is capable of producing high quality products. Whether the bottle fillers, capsule fillers, tablet presses and blenders are appropriate in their design and size. How frequently the instruments and their parts are cleaned and sanitized? How is the sterilization carried out (filtration, radiation, chemicals, or any other method)? Do you keep the records of calibration checks? Are the receipt, processing, sampling, testing, packaging, labeling and distribution performed strictly adhering to a formally written instructions or procedure?
Does the facility have designated premises to store raw materials, and whether you maintain the conditions (light, temperature, pH, humidity, etc.) in accordance to prevent raw materials from degradation? You also have to show them the sources of active ingredients and additives used in your company. There should be no expired raw materials in the storage house, and always store the inflammable and hazardous substances in safe conditions.
You have to give details to the inspector about the type of materials used for blister packaging and glass bottles, the frequency of QC in-charge visiting the packaging and labeling area, and whether or not there are well-defined SOPs on packaging materials, packaging operations and labeling.
Do you store the finished products in the same conditions mentioned on the label? Demonstrate that your company has sufficient space to orderly store the products that you don’t stuff up the raw materials, manufactured drugs and other packaging materials together. Upon approval from QC, are the products releases randomly or on FIFO (First In First Out) basis?