Quality inspection (Self-inspections & Benefits of Self Inspection)

Quality inspection (Self-inspections & Benefits of Self Inspection)

  • Principle
  • Importance and Benefits of Self Inspection
  • What is needed
  • Scope
  • How can self-inspection be conducted
  • Inspection Techniques
  • Example of Self-Inspection Plan
  • Who should be involved
  • Self-inspection report
  • Points to consider when performing self-inspection
  • Stages of Self-Inspection
  • Advantages & Disadvantages of Checklist

Principle

Self-inspections shall be conducted to monitor the implementation of corrective/preventive measures and compliance with Good Manufacturing Practice (GMP) principles and to propose necessary corrective measures.

Importance and Benefits of Self Inspection

To monitor and identify the shortcomings in implementation and evaluate compliance with the Good Manufacturing Practice principles and quality management system.

The company is able to address any issues internally and sooner, therefore, avoid potentially bigger problems

What is needed?

A pre-arranged program at regular intervals is needed to examine compliance with the Quality Assurance and shall cover:

– Personnel matters

– Premises, equipment

– Documentation, production

– Quality control

– Distribution of the products

– Arrangements for dealing with complaints and product recalls

– Self-inspection

Scope

– All aspects that might influence the quality of products shall be included in the scope of the self-inspections.

– Self-inspections shall assess and look at adequacy and compliance of systems, processes, premises and equipment, documents, etc.

– Areas for improvements could also be recommended.

– Implementing corrective/preventive measures

– Effective follow-up program towards any shortcomings in the implementation of GMP and

– Recommend the necessary corrective actions

– SOP needs to be followed which states the following:

  • Frequency (and the possible need to establish an audit plan)
  • The scope and standard to be used
  • How to record/report the self-inspection carried out
  • Training and experience for personnel involved in self-inspection,
  • The need to review previous reports’ classification of Nonconformities (NCs) with a corresponding desired timeframe to close out the NCs

The self-Inspection program/plan may cover

– All areas Cover in one single self-inspection (annually) or;

– have several self-inspections within a year (i.e. split the

Areas and perform self-inspections on several occasions)

– Provide a report for each self-inspection.

  • Self-inspection shall be conducted within seven days of the scheduled date.

Inspection Techniques

  • ASK
  • Observe
  • Check
  • Record

Who should be involved?

Self-inspection shall be conducted in an independent and detailed way by a designated competent person(s) from the company. Independent audits by external experts may also be useful.

Should consider having a self-inspection team with multiple representatives from different areas of work/responsibility.

Self-inspection should be conducted in an independent manner:

– No conflict of interest

– One shall not inspect his/her own work or area of work

  • Should conduct a thorough inspection that is objective and evidence-based.
  • Can consider using the approach used by regulatory inspectors.

Qualification of the self-inspection team:

  • Trained
  • Competent
  • Independent

– With the training and knowledge, self-inspection team members can then explore matters with the view to improve the system or address any gaps.

– Independent audits by external experts who have more experience in inspecting more companies can help to identify blind spots and suggest good practices for further improvement of the system.

Self-inspection report

All self-inspections shall be recorded. Reports shall contain all the observations made during the inspections and, where applicable, proposals for corrective actions and preventive actions, and corresponding time frames.

Statements on the actions subsequently taken shall also be recorded.

– Provide Evidence

– Allows traceability to all the follow-up actions to be taken

–To use a checklist, one must make sure that the checklist is appropriately designed and in a way to allow the recording of any Non-Conformance (NCs)

– Root cause identified for each Non-Conformance (NCs) and there should be corresponding Corrective / Preventive Actions (CAPAs)

– NCs that have a higher impact on the quality of the product shall be addressed sooner

– Should be followed through and closed out within a reasonable timeframe

– Record all objective evidence and what has been observed

Points to consider when performing self-inspection

Shall ask appropriate and right questions during self-inspections and shall focus on identifying flaws/gaps in processes and systems rather than finding faults in an Individual or nitpicking.

  • Use

Who

What

Where

When

Why

How rather than “closed questions” which will end up getting a “Yes” or “No” as an answer?

  • Superficial questions often produce superficial findings.

Shall create a win-win situation with the view to helping the organization to improve the processes and systems

  • Don’t just focus on hardware and documents, should also interview different personnel to verify the effectiveness of established systems or processes
  • Good and legible notes are essential to good inspection as you will never remember everything without notes.
  • Use the “trace-back” method
  • Include positive observations
  • Keep the report simple and clear

Stages of Self-Inspection

  • Planning
  • Performing
  • Reporting
  • Follow UP

Planning

Risk-based Inspection Programme

  • Management appoints a self-inspection team
  • Initiate self-inspection
  • prepare inspection schedule
  • Notify/brief the self-inspection team and auditee of the inspection plan
  • Allocate documents to team members for review and creation of checklists
  • Liaise with Management on inspection timing (including changes to timing)
  • Study documents and develop checklists (where applicable)

Performing

Conduct Opening Meeting

  • Conduct on-site self-inspection and record findings following suitable audit techniques
  • Document Review
  • Conduct Closing Meeting

Reporting

  • Prepare self-inspection report and classify the NCs by the team
  • Draft of the report reviewed by the auditee
  • Send inspection report to the auditee
  • Request corrective and preventive actions (CAPA) to address the NCs
  • Assigned personnel to identify the root cause to establish appropriate CAPA
  • Set time frame

Follow UP

Verification of CAPA, especially for critical and major NC

  • Present findings at Management Review meeting
  • Ensure follow-up on NCs until they are satisfactorily close-out By Lead Inspector.

Advantages of a Checklist

  1. Serve as a good inspection planning tool
  2. Help to focus on the essential parameters
  3. Serve as aids to memory
  4. Provide a useful means for quick recording of findings
  5. Help to maintain inspection direction

Disadvantages of a Checklist

  1. Inhibit flexibility
  2. Become a Questionnaire
  3. Encourage copy-cats inspection
  4. May discourage probing and investigation
  • The quality of an inspection depends to a great extent of the quality of the checklist.
  • There is a need to incorporate “impromptu questions in response to auditee’s responses. This requires much skill and experience.

EXAMPLE OF A SELF-INSPECTION PLAN

Quality Management – Quality Assurance, Quality Control, and Product Quality Review

Personnel – Organization, Qualification and Responsibilities, and Training

Premises and Equipment – Premises (including Production areas, Storage areas, Quality Control Areas, and Ancillary areas) and Equipment.

Sanitation and Hygiene – Personnel, Premises, Equipment, and Utensils

Documentation – Quality Control Documents, Specifications, Production Documents, Packaging Instructions, Batch Processing and Packaging Records, SOPs, and records

Production – Verification, Prevention of Cross-contamination, Starting Materials, Processing Operations, Packaging Materials, Packaging Operations, Finished Products, Rejected, Recovered, and Returned Materials

Quality Control – Sampling, Testing and On-Going Stability

Contract Manufacture and Analysis – Contract Manufacture, Contract Analysis, Contract Giver and Acceptor, and the Contracts

Complaints and Product Recall – Product Complaints, Product Recalls, and Complaints on Adverse Product Reactions.

Self-inspection – the robustness of a self-inspection program.

Verification – Documentation, Verification of Machinery and Equipment, Verification of Process, Change Control system

Self-inspection shall be carried out to review the following areas, but not limited to;

  • Location and surrounding
  • Building and premises
  • Water system
  • Disposal of waste
  • Handling of Hazardous waste disposal.
  • Warehousing area
  • Production area.
  • Ancillary areas
  • Quality Control area
  • Personnel.
  • Health, clothing and sanitation of workers.
  • Manufacturing Operations and Controls.
  • Precautions against mix-up and cross- contamination.
  • Sanitation in the manufacturing premises.
  • Raw materials
  • Equipment.
  • Documentation and records.
  • Labels and other printed materials.
  • Quality Assurance.
  • Self-Inspection and Quality Audit.
  • Quality Control System.
  • Specification.
  • Master Formula records.
  • Packaging Records.
  • Batch Manufacturing Records
  • Batch Packaging Records.
  • Data Integrity & Data Reliability
  • Standard Operating Procedures (SOPs) and Records, regarding.
  • Sampling.
  • Batch Numbering.
  • Testing, etc.
  • Audit Trials.
  • Records of analysis.
  • Reference samples.
  • Reprocessing and Recoveries.
  • Distribution Records.
  • Validation and Process Validation. / Process Qualification
  • Product recalls.
  • Complaints and Adverse Reactions.
  • NSQ (Not of standard quality).

Attachment 

  • Intimation of Self-Inspection Circular
  • List of Self-Inspection Audit team members
  • Self-Inspection Schedule
  • Self-Inspection Check List of Warehouse Department
  • Self-Inspection Check List of the Production Department
  • Self-Inspection Check List Quality assurance of department
  • Self-Inspection Check List of Quality control department
  • Self-Inspection Check List of the engineering department
  • Self-Inspection Check List of the human resource department
  • Self-Inspection Observation Point Report
  • Self-Inspection CAPA Submission Report

REFERENCES

  1. ASEAN Guidelines on Good Manufacturing Practices for Traditional Medicines.
  2. ASEAN Guidelines on Good Manufacturing Practices for Health Supplements.
  3. Good Manufacturing Practices for Pharmaceutical products: main principles, TRS 908 (2003) Annex 4.
  4. EU Chapter-9 Self Inspection

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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