GxP is a bunch of quality guidelines and benchmarks designed to ensure that your products are safe for patient use and adhere to quality standards consistently. GxP applies most readily to pharmaceutical and biopharmaceutical organizations through the requirements of USFDA 21 CFR Part 210 – 211.
List of GxP Compliance Checklist
1. Are all staff properly trained to perform the functions and activities of their roles? Is training linked to the relevant SOP(s) for that employee?
2. Does each employee have an associated record of scheduled and completed training, preferably directly accessible by that employee, indicating date, type of training, and binding wet or e-signature?
3. Do you assess and document the competency of employees on a regular basis?
4. Does each employee receive retraining on an SOP if operationally significant changes have been made to the procedure?
5. Are training records readily retrievable to ascertain and prove what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program?
6. Are company quality documents, GxP regulation literature and on-the-job training fully and properly provided to all new members of staff before they perform their duties?
7. Are all your GxP trainers properly qualified through experience and training?
8. Do you have an accurate organizational chart?
9. Are your consultants, contractors, suppliers, vendors and other third parties properly certified, trained and approved for that function?
10. Are written records maintained stating the name, address, qualifications and date of service for any consultants and the type of service they provide?
1. Do you have a central listing of all live Standard Operating Procedures (SOPs)?
2. Are SOPs available in their relevant business locations?
3. Do you have an overarching SOP governing how other SOPs are drafted, revised, distributed, controlled and archived?
4. Is there an SOP review schedule to ensure SOPs remain up-to-date, compliant and fit for purpose?
5. Are all QA procedures and responsibilities fully documented, current and approved?
6. Does a formal auditing function exist in the quality assurance department, with a documented SOP specifying audit personnel, scope/frequency of audits, and how reports are completed and distributed?
7. Are the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released?
8. Are complaints, whether received in oral or written form, documented in writing and retained in a designated file or electronic database?
9. Are complaints reviewed on a timely basis by your quality control unit, with documentation of any actions taken (or consciously not taken)?
10. Is a documented and approved quality policy made available to all employees?
11. Is there a change control system should amendments have to be made?
12. Are deviations from standard procedures fully documented?
13. Are corrective and preventative actions (CAPAs) fully documented alongside their relevant SOPs?
14. Does the QA department routinely review production records to ensure that procedures are followed and properly documented?
15. Are all materials handled in such a way as to prevent contamination and to allow for cleaning and inspection?
1. Do you have fully documented specifications for raw materials, components, intermediate and finished product?
2. Are standard methods followed for manufacture, packing, testing, sampling, status control, stability testing and records?
3. Do you have a mechanism in place for reporting and acting on quality events such as batch management, product deviations, change requests and so on?
4. Can you pinpoint who contributed to product development, and how, from the beginning to end of your product development history, with specific user, date and time information recorded in line with ALCOA+ principles?
5. Has each supplier/vendor of material or component products to your organization been inspected/audited for proper manufacturing controls according to a documented procedure?
6. Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification?
7. Are rejected components, material, and containers quarantined and clearly marked to prevent their use?
8. Are inventory control procedures written?
9. Is stock rotated to ensure that the oldest approved product or material is used first?
10. Do written procedures identify steps in the dispensing of material for production, including (1) release by QC, (2) documentation of correct weight or measure, (3) proper identification of containers and (4) observation and countersigning by a second person?
Premises & Equipment
1. Is your office, warehouse, manufacturing site and general working facility clean and properly maintained?
2. Is facility access restricted to approved personnel with a 24/7 security point of contact?
3. Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of your products, including available space, ventilation, lighting, air and water control?
4. Do you have operational environmental controls and a facility safety program, and are they regularly audited?
5. Do all staff have access to the correct safety equipment and PPE required for their role, with training completed before working in the GxP premises?
6. Do you have documented cleaning, sanitation, cross-contamination prevention and waste disposal SOPs?
7. Are adequate space, equipment and qualified personnel available for required testing?
8. Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material or finished product?
9. Are all pieces of equipment clearly identified with easily visible markings?
10. Do you have a documented process for validating and qualifying the equipment your organisation uses?
Processes & Security
1. Are your computer systems password-protected with individual user log-ins?
2. Do you have a live and visible information security policy?
3. Are your computer systems regularly backed up to prevent loss of data?
4. Do you have a continuity plan in place for IT disruption?
5. Do you have a continuity plan in place for IT disruption?
6. Are all changes to documents audit-trailed, with superseded versions replaced and stored in line with ALCOA+ principles?
7. Is there a Standard Operating Procedure for the storage, review, retention, and archiving of documents?
8. Are authority checks performed to ensure only authorized users can access your computerized systems?
9. Are computerized system actions signed off with FDA 21 CFR Part 11- and EU Annex 11-compliant e-signatures?
10. Are all computerized system processes fully traceable with audit trails in line with ALCOA+ principles?