Source: https://nbscience.com/sv/gmp-audit-checklist/
Timestamp: 2019-08-19 06:41:54
Document Index: 253598070

Matched Legal Cases: ['§211', '§211', '§211', '§211', '§211', '§211', '§211', 'arts 210', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211']

GMP Audit Checklist | Stem Cells terapi
Publicerad av NBScience på juli 29, 2019
Fråga Instructions/Questions
1.102 §211.22(en) Does a Quality Assurance unit (department) exist as a separate organizational entity?
1.103 §211.22(en) 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?
1.201 §211.22(en) 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?
1.203 §211.165(en)(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?
1.302 §211.25(en) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure?
1.307 §211.25(en) 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?
1.309 §211.25(en) Are temporary employees given the same orientation as permanent employees?
Not directly related to 21 CFR Parts 210 och 211
3.101 §211.42(en) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products?
3.301 §211.56(en) Is this facility free from infestation by rodents, birds, insects and vermin?
4.108 §211.65(en) Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-additive so as not to affect the product?
4.112 Is each idle piece of equipment clearly marked “needs cleaning” eller “cleaned; ready for service”?
4.115 §211.67(en)(b) Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material or finished product?
4.401 §211.68(en) Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions in notebook with cross reference.)
4.402 §211.68(en) Are records of calibration checks and inspections maintained in a readily retrievable manner?
4.502 §211.68(en) When computers are used to automate production or quality testing, have the computer and software been validated?
5.201 §211.80(en) Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.)
5.203 §211.82(en) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination?
5.403 §211.150(en) Is stock rotated to ensure that the oldest approved product or material is used first?
6.105 Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, och (3) Proper identification of containers?
6.109 §211.125(en) Does a written procedure specify who is authorized to issue labels?
6.110 §211.125(en) Does a written procedure specify how labels are issued, used, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies?
6.302 §211.100(en) Does the process control address all issues to ensure identity, strength, quality and purity of product?
6.303 §§211.101(en) Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients?
6.401 §211.110(en) Are written procedures established to monitor output and validate the performance of manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products?
6.501 §211.115(en) Do written procedures identify steps for reprocessing batches?
7.102 §211.134(en) För övrigt, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling?
7.103 §211.137(en) Are expiration dates stamped or imprinted on labels?
7.105 §211.142(en) Are all finished products held in quarantine until QC has completed its testing and releases product on a batch to batch basis for sale?
7.203 §211.170(en) Is a quantity of samples equal to at least twice the quantity needed for finished product release testing maintained as a reserve sample?
7.204 §211.167(en) Are sterility and pyrogen testing performed as required?
7.301 §211.150(en) Does a written procedure manage stocks to ensure that oldest approved product is sold first?
7.302 §211.150(en) Are deviations to the policy above documented?
7.303 §211.150(en) Does a written procedure identify the steps required if a product recall is necessary?
7.501 §211.198(en) Are complaints, whether received in oral or written form, documented in writing and retained in a designated file?
7.502 §211.198(en) Are complaints reviewed on a timely basis by the Quality Control Unit?
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