Audit checklist for who gmp guideline compliance in pharmaceuticals_Part 1

Dear all, here I provide a list of possible questions which an auditors are most likely going to ask and cheek for who gmp guideline compliance in pharmaceuticals inspection.

Before any inspection, hand over the copy of this to respective departments and make them ready for compliance of these questions.

Check pervious audit report , costumers feedback's , complaints etc and use this to verify the compliance for the particular point.

Following is the step by step guideline

With respect to requirements of who gmp guide for quality assuarance

• Does the pharmaceutical manufacturing firm ,organizational units ,operate in a state of control as defined by the GMP regulations? who gmp guidelines are followed? Check here YES / NO
• Organizational & Management Responsibilities for gmp. Check here YES / NO
• Does this facility/business unit operate under a facility or corporate quality policy? Check here YES / NO
• Does a Quality Assurance unit (department) exist as a separate organizational entity to ensuer all aspects of who gmp guide ? Check here YES / NO
• Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all components, drug product containers and closures, in-process materials, packaging materials, labeling and drug products? Check here YES / NO
• Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented with respect to GMP who gmp guide for quality assurance? Check here YES / NO
• Are adequate laboratory space, equipment, and qualified personnel available for required testing ? with respect to who gmp guide for quality assurance Check here YES / NO
• If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractor’s site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate? Check here YES / NO
• Date of last inspection:____________________
• Are all QA procedures in writing? with respect to who gmp guidelines,who gmp guide for quality assuarance Check here YES / NO
• Are all QA responsibilities in writing? with respect to who gmp guide for quality assuarance Check here YES / NO
• Are all written QA procedures current and approved? (Review log of procedures) Check here YES / NO
• Are the procedures followed? (Examine records to ensure consistent record-keeping that adequately documents testing.)Check here YES / NO
• Are QA supervisory personnel qualified by way of training and experience with respect to who gmp guide for quality assuarance? Check here YES / NO
• Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience with respect to who gmp guide for quality assuarance? Check here YES / NO

Document Control Program

• Does the QA unit have a person or department specifically charged with the responsibility of designing, revising, and obtaining approval for production and testing procedures, forms, and records ,with respect to who gmp guide for quality assurance? Check here YES / NO
• Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form ,with respect to who gmp guide for quality assurance? Check here YES / NO
• Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released? Check here YES / NO

Employee Orientation, Quality Awareness, and Job Training with respect to gmp

• Circle the types of orientation provided to each new employee: (1) Company brochure (2) Literature describing GMP regulations and stressing importance of following instructions. (3) On-the-job training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: enter in notebook. Check here YES / NO
• Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure? Check here YES / NO
• Indicate how on-going, periodic GMP training is accomplished. Check here YES / NO
• Is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer? Check here YES / NO
• Are training records readily retrievable in a manner that enables one to determine what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program? Check here YES / NO
• Are GMP trainers qualified through experience and training Check here YES / NO
• Are supervisory personnel instructed to prohibit any employee who, because of any physical condition (as determined by medical examination or supervisory observation) that may adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for finished product? Check here YES / NO
• Are employees required to report to supervisory personnel any health or physical condition that may have an adverse effect on drug product safety and purity? Check here YES / NO
• Are temporary employees given the same orientation as permanent employees?
• Are consultants, who are hired to advise on any aspect of manufacture, processing, packing or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience? Check here YES / NO
• Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide? Check here YES / NO

Plant Safety and Security

• Does this facility have a facility or corporate safety program? Check here YES / NO
• Are safety procedures written? Check here YES / NO
• Are safety procedures current? Check here YES / NO
• Do employees receive safety orientation before working in the plant area? Check here YES / NO
• Is safety training documented in a readily retrievable manner that states the name Check here YES / NO
• of the employee, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant? Check here YES / NO
• Does this facility have a formal, written security policy? Check here YES / NO
• Is access to the facility restricted? Check here YES / NO
• Describe how entry is monitored/restricted: Check here YES / NO
• Is a security person available 24 hours per day? Check here YES / NO
  
  

Internal Quality/who gmp Audit Program

• Does this business unit/facility have a written quality policy? Check here YES / NO
• Is a copy of this quality policy furnished to all employees? Check here YES / NO
• If "yes" to above, when provided? __________________
• Is training provided in quality improvement? Check here YES / NO
• Does a formal auditing function exist in the Quality Assurance department? Check here YES / NO
• Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits? Check here YES / NO
• Does a written SOP specify the scope and frequency of audits and how such audits are to be documented? Check here YES / NO
• Does a written SOP specify the distribution of the audit report? Check here YES / NO

Quality Cost Program for gmp cgmp

• Does this facility have a periodic and formal review of the cost of quality? Check here YES / NO
• Does this facility have the ability, through personnel, software, and accounting Check here YES / NO
• Records, to identify and capture quality costs? Check here YES / NO
• Does this facility make a conscious effort to reduce quality costs? Check here YES / NO

Reference: WHO guideline for GMP/Internet