Source: https://nbscience.com/it/gmp-audit-checklist/
Timestamp: 2019-08-19 05:35:44
Document Index: 665466134

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

Audit di controllo GMP | La terapia cellule staminali
Pubblicato da NBScience sopra luglio 29, 2019
Domanda Instructions/Questions
Does the facility and its many departments (unità organizzative) operate in a state of control as defined by the GMP regulations?
1.1 organizzativa & Management Responsibilities
1.105 §211.22(B) Are adequate laboratory space, attrezzatura, 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, attrezzatura, qualified personnel and procedures are adequate?
1.113 §211.25 Are other QA personnel, es, chemists, analysts, tecnici di laboratorio) qualified by way of training and experience?
1.201 §211.22(un) 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, forme, and records?
1.203 §211.165(un)(B)(c) Is the production batch record and release test results reviewed for accuracy and completeness prima 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 (prima the employee is allowed to perform such tasks). (4) Altro: enter in notebook.
1.302 §211.25(un) Does each employee receive retraining on an SOP (procedure) if critical changes have been made in the procedure?
1.310 §211.34 Are consultants, who are hired to advise on any aspect of manufacture, in lavorazione, packing or holding, of approval for release of drug products, asked to provide evidence of their education, formazione, and experience?
1.311 §211.34 Are written records maintained stating the name, indirizzo, qualifications, and date of service for any consultants and the type of service they provide?
1.404 Do employees receive safety orientation prima working in the plant area?
1.506 Does a written SOP specify who shall conduct audits and qualifications (education, formazione, and experience) for those who conduct audits?
Not directly related to 21 CFR Parts 210 e 211
3.101 §211.42(un) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, analisi, and holding of drug products?
3.205 §211.46 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, in lavorazione, storage or testing of drug products?
3.302 §211.56(c) Does this facility have written procedures for the safe use of suitable, (es. 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, metodi, equipment and material?
3.402 §163 Are contractors qualified by experience or training to perform tasks that may influence the production, confezione, 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, Altro (specify).
4.103 Are the following pieces of equipment suitable in their size/capacity? Blender(S), Conveyor(S), Tablet, Presses, Capsule Fillers, Bottle Fillers, Altro (specify).
4.104 Are the following pieces of equipment suitable in their design? Blender(S), Conveyor(S), Tablet, Presses, Capsule Fillers, Bottle Fillers, Altro (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, Altro (specify).
4.106 Are the following pieces of equipment properly installed? Blender(S), Conveyor(S), Tablet, Presses, Capsule Fillers, Bottle Fillers, Altro (specify).
4.107 Is there adequate space for the following pieces of equipment? Blender(S), Conveyor(S), Tablet, Presses, Capsule Fillers, Bottle Fillers, Altro (specify).
4.115 §211.67(un)(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 & Pulizia
4.501 §211.63 Verify that all pieces of equipment used in production, confezione, and quality assurance are capable of producing valid results.
5.2 Material/Component Receipt, Inspection, campionatura, and Laboratory Testing
5.305 §211.122(d) Are labels for different products, strengths, dosage forms, eccetera., stored separately with suitable identification?
5.402 Does the program identify destruction dates for obsolete or out-dated materials, componenti, and packaging materials?
5.403 §211.150(un) Is stock rotated to ensure that the oldest approvato product or material is used first?
6.1 Material/Component/Label Verification, Conservazione, and Handling
6.105 Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, e (3) Proper identification of containers?
6.110 §211.125(un) Does a written procedure specify how labels are issued, Usato, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies?
6.4 In-Process Inspection, campionatura, and Laboratory Control
6.402 §211.110(c) Are in-process materials tested at appropriate phases for identity, strength, qualità, purity and are they approved or rejected by Quality Control?
7.1 Finished Product Verification, Conservazione, and Handling
7.102 §211.134(un) Inoltre, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling?
7.106 §211.142(il) Is finished product stored under appropriate conditions of temperature, humidity, leggero, eccetera.
7.2 Finished Product Inspection, campionatura, analisi, and Release for Distribution
tag: Audit di controllo GMP
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