AUDIT SCHEDULE … QUALITY ASSURANCE SERVICES

Scott Bryson

Description

AUDIT SCHEDULE QUALITY ASSURANCE SERVICES PRODUCED BY A WORKING GROUP OF THE SCOTTISH QUALITY ASSURANCE SPECIALIST INTEREST GROUP September 2003 First Edition AUDIT SCHEDULE – QUALITY ASSURANCE SERVICES INTRODUCTION SCOPE Quality Assurance services to pharmacies This includes analytical and microbiological testing, medical gas testing and environmental monitoring This schedule contains some sections which may not be applicable to all areas audited: these should be omitted. AIMS OF A QUALITY ASSURANCE SERVICE To provide assurance that medicinal products supplied from, and services provided by, a pharmacy are fit for their intended purpose. AIMS OF THE AUDIT a) To assess compliance with agreed standards for quality assurance services b) To identify actions required to rectify shortcomings of the Quality Assurance service c) To ensure that pharmaceutical services are operating to agreed standards ACCEPTANCE CRITERIA a) A list of criteria has been drawn up by QA staff b) The criteria encompass various components of the service, e.g. personnel, sampling etc. c) The criteria will be reviewed and revised as necessary by the Scottish Quality Assurance Specialist Interest Group at regular intervals. METHODS OF MONITORING Auditors will use the following methods to assess compliance: ASSESS: Subjective views obtained from observation and/or discussion with ...

Informations

• Publié par: Unya
• Nombre de lectures: 87
• Langue: English

Extrait

 

 

 

 

  

AUDIT SCHEDULE

QUALITY ASSURANCE SERVICES

                                  Se tember 2003 First Edition       

PRODUCED BY A WORKING GROUP OF THE SCOTTISH QUALITY ASSURANCE SPECIALIST INTEREST GROUP

 AUDIT SCHEDULE – QUALITY ASSURANCE SERVICES           INTRODUCTION   SCOPE Quality Assurance services to pharmacies  This includes analytical and microbiological testing, medical gas testing and environmental monitoring  This schedule contains some sections which may not be applicable to all areas audited: these should be omitted.     AIMS OF A QUALITY ASSURANCE SERVICE    To provide assurance that medicinal products supplied from, and services provided by, a pharmacy are fit for their intended purpose.   AIMS OF THE AUDIT   a) To assess compliance with agreed standards for quality assurance services b) To identify actions required to rectify shortcomings of the Quality Assurance service c) To ensure that pharmaceutical services are operating to agreed standards   ACCEPTANCE CRITERIA     a) A list of criteria has been drawn up by QA staff b) The criteria encompass various components of the service, e.g. personnel, sampling etc. c) The criteria will be reviewed and revised as necessary by the Scottish Quality Assurance Specialist Interest Group at regular intervals.   METHODS OF MONITORING    Auditors will use the following methods to assess compliance:   ASSESS: Subjective views obtained from observation and/or discussion with relevant personnel; EXAMINE: Physical inspection of premises, equipment and/or written procedures; OBSERVE: Personal inspection of tasks being undertaken; RECORDS: Reference to current or previous records of tests or procedures having been performed.  

 

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INTRODUCTION (continued)

    SCORING SYS TEM    Y: Complete compliance with accepted criteria  P: Partial compliance  N: Does NOT Comply  N/A: Not applicable   REFERENCES       Current editions of the following standards and guidelines may be referred to in the course of the audit:   National Guidelines:   •
Rules and Guidance Pharmaceutical Manufacturers and Distributors for •
BS EN ISO 9002 •
‘Quality Assurance of Aseptic Preparation Services’ ed. A. Beaney •
ASSIG/QASIG aseptic audit schedule •
QASIG microbiology audit schedule •
British Pharmacopoeia •
Relevant QASIG/ASSIG Guidelines   Documentation, including:   •
Departmental Policy Manual •
Organisational Structure of Department •
Responsibilities of staff/job descriptions •
Standard Operating Procedures (SOP) •
Worksheets •
Cleaning Records •
Training Records •
Equipment Logs      

 

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   INTRODUCTION (continued)     APPENDIX 1: AUDIT RECORD   The audit record included at the end of the schedule may be completed by the Auditors to provide a summary of the sections audited, since some of the sections may not apply to the particular service provided.   APPENDIX 2: AUDIT REPORT             NOTES          

 

   

     

The audit report included at the end of the schedule may be completed by the auditors to provide a summary of the deficiencies noted during the audit.

There may be some overlap between sections, but this is unavoidable if it is accepted that not all of the sections below will be relevant for every Quality Assurance Department. This is a broad ranging series of topics covering many sections of relevance to pharmacy in general: the auditors may choose some sections, and omit others, to suit individual circumstances.

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          Part 1 Part 2 Part 3 Part 4 Part 5 Part 6 Part 7 Part 8 Part 9 Part 10 Part 11 Part 12 Part 13 Part 14 Part 15 Part 16 Part 17 Part 18 Part 19 Part 20 Part 21 Part 22 Part 23 Part 24 Part 25

 

 

                                                 

 AUDIT SCHEDULE - QUALITY ASSURANCE SERVICES

 CONTENTS

Premises  Personnel Documentation  Sampling Raw Materials (starting materials and packaging) Analytical Testing Equipment  Health & Safety/COSHH Contract Services Complaints and Product Recall Environmental Monitoring Microbiological Testing Validation/Qualification Storage and Stock Control Internal and External Audit Risk Management Audit Approval of Finished Products Calibration/Monitoring Incident Reporting (including Drug Alerts) Medical gases Environmental Monitoring Unlicensed Medicines Clinical Trials Extemporaneous Dispensing

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            AUDIT OF QUALITY ASSURANCE SERVICES   PART 1 – Premises   ACCEPTANCE CRITERIA AUDIT RESULT   1. PREMISES   1.1 Laboratories are of adequate size for the range of activities Y P N N/A undertaken 1.2 There is sufficient storage space Y P N N/A 1.3 The fabric is in a good state of repair Y P N N/A    1.4 Quarantine areas are clearly defined Y P N N/A 1.5 There is adequate separation/segregation of microbiological Y P N N/A materials 1.6 Effi possible Y P N N/A cient and effective workflow is 1.7 Working areas are clean and tidy Y P N N/A 1.8 There are separate areas for ‘goods in’ and ‘goods out’ Y P N N/A 1.9 There is a separate Domestic Services Room Y P N N/A 1.10 Allowance has been made for special conditions for equipment, Y P N N/A e.g. vibration-proofing for balances 1.11 Allowance has been made for special conditions to protect Y P N N/A staff, e.g. dust extraction from balances 1.12 The premises are secured with an appropriate intruder alarm Y P N N/A 1.13 There is a separate cloakroom area with secure lockers Y P N N/A 1.14 There is a dedicated area for the sampling of raw mater Y P N N/A ials                            

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COMMENTS/ACTION                              

AUDIT OF QUALITY ASSURANCE SERVICES   n l PART 2 – Person e   ACCEPTANCE CRITERIA AUDIT RESULT   2. PERSONNEL 2.1 The laboratory is under the control of a staff member who is Y P N N/A responsible for all aspects of the service 2.2 In the absence of the responsible staff member, an assigned Y P N N/A deputy is available 2.3 There is a documented programme to train staff in accordance Y P N N/A with departmental procedures 2.4 Staffing numbers are sufficient for the workload Y P N N/A 2.5 Staff are appropriately qualified Y P N N/A 2.6 The organisational structure of the department is clearly defined Y P N N/A 2.7 Roles and responsibilities of all staff are clearly defined Y P N N/A 2.8 Staff are in possession of an up-to-date job description Y P N N/A 2.9 The appropriate Tru y nuals are available   st Polic Ma to all staff including: 2.9.1 Health & Safety   2.9.2 Control of Infection Y P N N/A     2.9.3 Fire Y P N N/A 2.10 Only approved competent staff are eligible to participate in Y P N N/A operating procedures 2.11 New staff attend a Staff Induction Programme within 3 months Y P N N/A of appointment 2.12 Training is individualised for the relevant staff groups Y P N N/A 2.13 Copies of individual training records are kept in the QC Y P N N/A department and in the Personnel files 2.14 There is evidence of continuing assessment of competencies of Y P N N/A staff 2.15 There is a written departmental policy covering personal Y P N N/A health, hygiene and clothing                  

 

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COMMENTS/ACTION                                      

AUDIT OF QUALITY ASSURANCE SERVICES   3 – Documentatio PART n     ACCEPTANCE CRITERIA AUDIT RESULT   3. DOCUMENTATION 3.1 There is an approved procedure in place for the control of Y P N N/A documentation 3.2 The policy in ions on    cludes sect a) change control and Y P N N/A b) control of electronic documents Y P N N/A 3.3 Documents, approved and signed by appropriate persons, are     available and include: 3.3.1 Instructions for use of equipment Y P N N/A    3.3.2 SOP’s for all processes Y P N N/A 3.3.3 Training manuals Y P N N/A 3.3.4 Training records Y P N N/A 3.3.5 Analytical reports Y P N N/A 3.3.6 Product specifications Y P N N/A 3.3.7 Approved suppliers Y P N N/A 3.3.8 Environmental monitoring results Y P N N/A 3.3.9 Routine function checks Y P N N/A 3.3.10 Calibration results Y P N N/A 3.3.11 Validation results Y P N N/A 3.3.12 Non-conformance reports Y P N N/A 3.3.13 Error reports Y P N N/A   3.3.14 Re-assay procedures Y P N N/A 3.3.15 Procedure for dealing with out-of-specification results Y P N N/A 3.4 An approved Quality Manual is available Y P N N/A 3.5 There is an up-to-date Site Master File (Licensed sites only) Y P N N/A 3.6 All documents are clear and unambiguous Y P N N/A 3.7 Completed worksheets are filed and allow traceability Y P N N/A 3.8 Documents are filed for the appropriate period according to Y P N N/A local policy 3.9 All SOP's are current and have an appropriate review date (e.g. Y P N N/A     every 2 years)            

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COMMENTS/ACTION                                                  

AUDIT OF QUALITY ASSURANCE SERVICES     PART 4 – Sampling     ACCEPTANCE CRITERIA AUDIT RESULT   4. SAMPLING 4.1 Samples for analysis are taken in accordance wit approved   h written procedures detailing: 4.1.1 Method of sampling Y P N N/A 4.1.2 Amount of sample to be taken Y P N N/A 4.1.3 Type of sampling equipment used Y P N N/A 4.1.4 Number of containers to be sampled Y P N N/A 4.1.5 Type of sampling container to be used Y P N N/A 4.1.6 Special handling precautions for hazardous materials Y P N N/A 4.1.7 Appropriate storage conditions for samples Y P N N/A 4.1.8 Instructions for cleaning sampling equipment Y P N N/A 4.2 Labels on sample containers show:   4.2.1 Name and Grade of product Y P N N/A 4.2.2 A unique reference number Y P N N/A 4.2.3 Date sample taken Y P N N/A 4.2.4 Number of containers sampled (e.g. ‘1 of 5’) Y P N N/A 4.3 The quantity of sample taken is adequate for the amount of Y P N N/A testing to be carried out 4.4 Sufficient sample is taken to permit re-testing Y P N N/A 4.5 Samples are retained for a suitable time:   4.5.1 Finished products – shelf life of product + one year Y P N N/A 4.5.2 Raw materials – two years post-release of finished product Y P N N/A 4.6 Reference samples taken from manufactured products are Y P N N/A representative of the batch produced 4.7 Samples for analysis are representative of the greatest stress – e.g Y P N N/A first and last 4.8 Sterility test samples from terminally sterilised batches are taken Y P N N/A from the coolest parts of the load as indicated by 12-point recorder testing 4.9 The numbers of samples taken for sterility testing is in Y P N N/A accordance with the requirements of the BP 4.10 Sterility test samples from aseptically prepared products include Y P N N/A the first and last container filled         

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COMMENTS/ACTION                                              

   

AUDIT OF QUALITY ASSURANCE SERVICES     PART 4 – Sampling (continued)   ACCEPTANCE CRITERIA 4. SAMPLING 4.11 Staff training in sampling techniques includes: 4.11.1 Sampling plans 4.11.2 Sampling procedures 4.11.3 Avoidance of cross-contamination 4.11.4 Handling precautions to protect staff 4.11.5 Handling precautions to protect product 4.11.6 Reporting out-of-specification findings

 

AUDIT RESULT      Y P N N/A Y P N N/A Y P N N/A Y P N N/A Y P N N/A Y P N N/A

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COMMENTS/ACTION                

AUDIT RESULT    

  AUDIT OF QUALITY ASSURANCE SERVICES   PART 5– Raw Materials (starting materials, packaging and labels)   ACCEPTANCE CRITERIA   5. RAW MATERIALS (Raw materials include starting materials, packaging and labels) 5.1 An approved policy on testing and retesting of raw materials is in Y P N N/A place 5.2 A list of approved suppliers is available Y P N N/A 5.3 Optimal pack sizes in terms of use, volume and cost are Y P N N/A purchased 5.4 Raw materials suppliers are assessed regularly Y P N N/A 5.5 An identity test is performed on every container of starting Y P N N/A materials 5.6 Tests carried out on raw materials are designed to reflect the Y P N N/A nature of the product and its final use 5.7 The critical dimensions of primary containers are tested against Y P N N/A an approved specification 5.8 Certificates of Analysis are obtained for all raw materials Y P N N/A 5.9 Certificates of Analysis are reviewed to ensure that they conform Y P N N/A with the approved specification 5.10 Written approved specifications are available for all raw Y P N N/A materials in use 5.11 Confirmation of TSE-free status of relevant starting materials Y P N N/A is obtained from suppliers    

 

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COMMENTS/ACTION