Source: https://nbscience.com/de/gmp-audit-checklist/
Timestamp: 2019-12-10 16:53:30
Document Index: 137878421

Matched Legal Cases: ['§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', '§211', 'arts 210', '§211', '§211', '§211', '§211', '§163', '§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', '§211']

GMP-Audit-Checkliste | Stammzellen-Therapie
Veröffentlicht von NBScience am Juli 29, 2019
Frage Instructions/Questions
Does the facility and its many departments (Organisationseinheiten) operate in a state of control as defined by the GMP regulations?
1.1 organisatorisch & Management Responsibilities
1.102 §211.22(ein) Does a Quality Assurance unit (department) exist as a separate organizational entity?
1.103 §211.22(ein) 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?
1.105 §211.22(b) Are adequate laboratory space, Ausrüstung, and qualified personnel available for required testing?
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, Ausrüstung, qualified personnel and procedures are adequate?
1.113 §211.25 Are other QA personnel, z.B., chemists, analysts, Labortechniker) qualified by way of training and experience?
1.201 §211.22(ein) 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(ein)(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?
1.301 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) Andere: enter in notebook.
1.302 §211.25(ein) Does each employee receive retraining on an SOP (Verfahren) if critical changes have been made in the procedure?
1.307 §211.25(ein) 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(ein) 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, wird bearbeitet, packing or holding, of approval for release of drug products, asked to provide evidence of their education, Ausbildung, and experience?
1.506 Does a written SOP specify who shall conduct audits and qualifications (education, Ausbildung, and experience) for those who conduct audits?
Not directly related to 21 CFR Parts 210 und 211
3.101 §211.42(ein) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testen, and holding of drug products?
3.205 §211.46 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, wird bearbeitet, storage or testing of drug products?
3.301 §211.56(ein) Is this facility free from infestation by rodents, birds, insects and vermin?
3.302 §211.56(c) Does this facility have written procedures for the safe use of suitable, (z.B.. those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents?
3.304 Does this facility have written procedures that describe in sufficient detail the cleaning schedule, Methoden, equipment and material?
3.402 §163 Are contractors qualified by experience or training to perform tasks that may influence the production, Verpackung, or holding of drug products?
4.102 Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Andere (specify).
4.103 Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Andere (specify).
4.104 Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Andere (specify).
4.105 Are the locations in the facility of the following pieces of equipment acceptable? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Andere (specify).
4.106 Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Andere (specify).
4.107 Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Andere (specify).
4.108 §211.65(ein) 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” oder “cleaned; ready for service”?
4.115 §211.67(ein)(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?
4.3 Equipment Maintenance & Reinigung
4.401 §211.68(ein) 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(ein) Are records of calibration checks and inspections maintained in a readily retrievable manner?
4.501 §211.63 Verify that all pieces of equipment used in production, Verpackung, and quality assurance are capable of producing valid results.
4.502 §211.68(ein) When computers are used to automate production or quality testing, have the computer and software been validated?
5.2 Material/Component Receipt, Inspection, Probenahme, and Laboratory Testing
5.201 §211.80(ein) 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(ein) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination?
5.402 Does the program identify destruction dates for obsolete or out-dated materials, Komponenten, and packaging materials?
5.403 §211.150(ein) Is stock rotated to ensure that the oldest genehmigt product or material is used first?
6.1 Material/Component/Label Verification, Lager, and Handling
6.105 Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, und (3) Proper identification of containers?
6.109 §211.125(ein) Does a written procedure specify who is authorized to issue labels?
6.110 §211.125(ein) Does a written procedure specify how labels are issued, benutzt, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies?
6.302 §211.100(ein) Does the process control address all issues to ensure identity, strength, quality and purity of product?
6.303 §§211.101(ein) Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients?
6.4 In-Process Inspection, Probenahme, and Laboratory Control
6.401 §211.110(ein) 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?
6.402 §211.110(c) Are in-process materials tested at appropriate phases for identity, strength, Qualität, purity and are they approved or rejected by Quality Control?
6.501 §211.115(ein) Do written procedures identify steps for reprocessing batches?
7.1 Finished Product Verification, Lager, and Handling
7.102 §211.134(ein) In Ergänzung, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling?
7.103 §211.137(ein) Are expiration dates stamped or imprinted on labels?
7.105 §211.142(ein) Are all finished products held in quarantine until QC has completed its testing and releases product on a batch to batch basis for sale?
7.106 §211.142(die) Is finished product stored under appropriate conditions of temperature, humidity, Licht, etc.
7.2 Finished Product Inspection, Probenahme, Testen, and Release for Distribution
7.203 §211.170(ein) 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(ein) Are sterility and pyrogen testing performed as required?
7.301 §211.150(ein) Does a written procedure manage stocks to ensure that oldest approved product is sold first?
7.302 §211.150(ein) Are deviations to the policy above documented?
7.303 §211.150(ein) Does a written procedure identify the steps required if a product recall is necessary?
7.501 §211.198(ein) Are complaints, whether received in oral or written form, documented in writing and retained in a designated file?
7.502 §211.198(ein) Are complaints reviewed on a timely basis by the Quality Control Unit?
Schlagwörter:GMP-Audit-Checkliste
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