The document 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials', published as part of the Community procedures, states that it is expected that manufacturing-authorisation holders will gain assurance that the active substances they use are manufactured in accordance with GMP through audit of the active-substance suppliers. Small manufacturers may not have the necessary expertise or resource to conduct their own audits.
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Section 5.25 of the GMP guideline requires starting materials to be purchased from approved suppliers and about whom the manufacturer has a particular and thorough knowledge.
An audit conducted by the manufacturing-authorisation holder itself should be integral to the manufacturer's quality-assurance system and subject to the basic GMP requirements, i.e. conducted by properly qualified and trained staff, in accordance with approved procedures. It should be properly documented. These aspects can be inspected as necessary by the competent authorities.
If a third party is involved, the arrangements should be subject to chapter 7 of the GMP guideline. There should be evidence that the contract-giver has evaluated the contract-acceptor with respect to the aspects described above.
All parties involved should be aware that audit reports and other documentation relating to the audit will be made available for inspection by the competent authorities if requested. This should normally provide sufficient assurance that the results of an audit carried by the third party are credible, thus waiving the need for an audit conducted by the manufacturing-authorisation holder itself. However, it must also be satisfactorily demonstrated that there are no conflicts of interests. Conflicts of interests could arise for example from:
This topic should also be addressed in the technical contractual arrangements. Any measures taken by the contract-giver should be documented, e.g. signed undertakings by the auditors.
Similarly, the principles outlined above could be used to allow sharing of audit reports between different manufacturing-authorisation holders using the same active substance supplier, provided that the scope of the audits can be shown to be applicable to the active substances of mutual interest.
Does the facility and its many departments (organizational units) operate in a state of control as defined by the GMP regulations?
1.1
Organizational & Management Responsibilities
1.101
Does this facility/business unit operate under a facility or corporate quality policy?
1.102
§211.22(a) Does a Quality Assurance unit (department) exist as a separate organizational entity?
1.103
§211.22(a) 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?
1.104
§211.22 Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented?
1.105
§211.22(b) Are adequate laboratory space, equipment, and qualified personnel available for required testing?
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1.106
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?
1.107
Date of last inspection:____________________
1.108
§211.22(c) Are all QA procedures in writing?
1.109
§211.22(c) Are all QA responsibilities in writing?
1.110
Are all written QA procedures current and approved? (Review log of procedures)
1.111
Are the procedures followed? (Examine records to ensure consistent record-keeping that adequately documents testing.)
1.112
§211.25 Are QA supervisory personnel qualified by way of training and experience?
1.113
§211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience?
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1.201 §211.22(a) 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? 1.202 §211.22(d) Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form? 1.203 §211.165(a)(b)(c) Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released? 1.3 Employee Orientation, Quality Awareness, and Job Training 1.301 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. 1.302 §211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure? 1.303 Indicate how on-going, periodic GMP training is accomplished. 1.304 §211.25 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? 1.305 §211.25 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? 1.306 Are GMP trainers qualified through experience and training? 1.307 §211.25(a) 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? 1.308 §211.28(d) 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? 1.309 §211.25(a) Are temporary employees given the same orientation as permanent employees? 1.310 §211.34 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? 1.311 §211.34 Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide? 1.4 Plant Safety and Security 1.401 Does this facility have a facility or corporate safety program? 1.402 Are safety procedures written? 1.403 Are safety procedures current? 1.404 Do employees receive safety orientation before working in the plant area? 1.405 Is safety training documented in a readily retrievable manner that states the name 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? 1.406 Does this facility have a formal, written security policy? 1.407 Is access to the facility restricted? 1.408 Describe how entry is monitored/restricted: 1.409 Is a security person available 24 hours per day? 1.5 Internal Quality/GMP Audit Program 1.501 Does this business unit/facility have a written quality policy? 1.502 Is a copy of this quality policy furnished to all employees? 1.503 If "yes" to above, when provided? __________________ 1.504 Is training provided in quality improvement? 1.505 Does a formal auditing function exist in the Quality Assurance department? 1.506 Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits? 1.507 Does a written SOP specify the scope and frequency of audits and how such audits are to be documented? 1.508 Does a written SOP specify the distribution of the audit report? 1.6 Quality Cost Program 1.601 Does this facility have a periodic and formal review of the cost of quality? 1.602 Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs? 1.603 Does this facility make a conscious effort to reduce quality costs?