Audit Deficiencies – How does your organisation compare with others?

audit-deficiencies

Audit Deficiencies – How does your organisation compare with others?

Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others with respect to audit deficiencies?

Audit Deficiencies Reported by the TGA

The Australian Therapeutic Goods Administration (TGA) released their Good Manufacturing Practices Annual Report 2019-2020 in November 2020. The common deficiencies reported by the TGA were:

Deviations:

  • Poor investigations and poor root cause analysis
  • No root cause analysis performed
  • Poor Corrective and Preventative Action Plan (CAPA)

Computerised Systems:

  • Electronic system used for QMS processes not validated
  • Back up of data not performed
  • Lack of audit trails
  • Inadequate procedures and access control

Environmental monitoring:

  • Inadequate environmental controls specified
  • Inadequate frequency of environmental monitoring

Validation:

  • Inadequate cleaning validation
  • Poor process validation
  • Poor equipment validation
  • Poor validation identification
  • Validation not performed to procedures
  • Validations do not always demonstrate full control of the manufacturing process

The US Food and Drug Administration (FDA) publish their annual inspection observations on their website. The most recent data set for the 2020 financial year reported the following common deficiencies:

CAPA:

  • Inadequate procedures for corrective and preventive action
  • CAPA activities and/or results not adequately documented

Complaints:

  • Inadequate procedures for receiving, reviewing and evaluating complaints by a formally designated unit
  • Inadequate maintenance of complaint files
  • Poor investigation of complaints
  • Rationale not documented for no investigation

Quality Control Unit:

  • Inadequate quality control personnel
  • Quality Control Unit responsibilities not documented or fully followed

Production discrepancies/failures:

  • Inadequate investigation of discrepancies
  • Investigations do not always include conclusions and follow up

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reported in 2019 that the highest number of  audit deficiencies related to:

  • Quality Systems
  • Documentation
  • Production
  • Qualification and Validation
  • Premises and Equipment

At PharmOut, our consultants have assisted several pharmaceutical, medical device and other life science industry clients with their Internal Audits and External Supplier/Manufacturer Audits to international standards and regulations, including PIC/S GMP, ISO 9001, ISO 13485, and MDSAP.

Here are 10 of the most common audit deficiencies identified at audits conducted by PharmOut: 

  1. Quality Policy and Quality Objectives
  • Quality objectives are not SMART – Specific, Measurable, Achievable, Realistic and Time-bound
  • Staff not trained on the quality policy or quality objectives
  1. Training Program
  • Training matrices and training records not available
  • Revision numbers of procedures and date of training not recorded
  • Competency assessments and effectiveness of training not determined
  1. Supplier Management and Quality Agreements
  • Quality agreements not in place or out of date
  • Inadequate assessment and approval of suppliers
  • Supplier audits not performed
  • Approved supplier list not in place
  • Frequency of supplier monitoring not determined
  1. Validation
  • Process validation not adequately performed
  • Cleaning validation not performed and inadequate cleaning procedures
  • Computerised systems not validated & procedures not in place (data storage, data backup, disaster recovery, access control)
  1. Data Integrity
  • Lack of traceability to individuals recording quality data
  • QMS excel spreadsheets not validated, or password protected
  • Excel spreadsheets used instead of forms for recording quality data
  • Original quality records missing
  • Incomplete quality records
  1. Internal Audits
  • Internal audits not performed
  • Internal audit report not issued within specified time frames
  • Audit findings not appropriately tracked and implemented
  1. Handling and Storage of Product
  • Rejected product not segregated
  • Over capacity of storage areas
  1. Risk Management
  • Lack of risk management implemented across QMS processes
  • Investigations not performed based on level of risk
  • Risk assessments not appropriately performed
  1. QMS Records
  • Large number of open change controls, non-conformances, customer complaints and CAPAs
  • Change controls not raised
  • Criticality and risk of changes & non-conformances not defined
  • Actions not appropriately tracked and closed out
  • Lack of pre-approval of changes by Quality
  • Timelines for completing investigations not adhered to
  • Root cause not appropriately determined
  • Effectiveness checks of CAPAs not performed
  1. Management Review
  • Management review schedule not in place
  • Management review not completed
  • Actions from management review not tracked and implemented

Please contact PharmOut to enquire about our auditing services. We can facilitate both on-site and remote auditing, as well as provide recommendations and guidance on addressing and resolving your audit deficiencies

Read more blogs about audit findings and deficiencies

 

Responding to Regulatory Audit Findings

 

As a TGA GMP consultant, I’m often asked… “Do you have any examples of Critical and Major deficiencies?”