Wednesday 22 August 2018

ISO 14644 - The Revised Standard and Implications for Cleanrooms (webinar)

The international standard for cleanrooms has undergone a major revision. This webinar discusses the revisions in the context of global GMPs and the overall contamination control strategy. The webinar discusses testing approaches and the assessment of test data. The learning point is with keeping cleanrooms compliant.

New webinar - Date: Thursday, 30 August 2018 | Time: 10:00 AM PDT, 01:00 PM EDT | Duration: 60 Minutes

  • How to assess a cleanroom as built, at rest and in operation
  • How cleanroom standards inter-link to global GMPs
  • How to evaluate cleanroom data
  • How to assess cleanroom contractors
  • The importance of a risk based approach
  • Assessing microbial and particulate risks
This presentation will review the changes to ISO 14644 Parts 1 and 2 and will focus on the factors to consider when performing your risk assessment and creating your monitoring plan. How do justify sampling locations for classification? How often are you going to perform period reclassification? What about the other ancillary cleanroom testing required in ISO 14644-3? How often will you perform that based on risk? What items should you include in your monitoring plan document? Changes to these ISO standards will impact the way you perform cleanroom classification activities. Everything you need to know to be compliant to the changes.

See: Online Compliance Panel (

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday 8 August 2018

Pharmig News #72

A new edition of Pharmig News has been issued. In this edition:
  • Pharmig events update
  • Review of Pharmig Irish conference and risk management by Tim Sandle
  • Brexit uncertainty by Tim Sandle
  • Latest regulatory news
  • And more!

Copies will have been sent to member organisations. To see a copy, please email Pharmig at:

Tim Sandle's articles in this edition are:

Sandle, T. (2018) Microbiology Risk Management (QRM): a practical approach meeting, Pharmig News, Issue 72, pp2-4

Sandle, T. (2018) Brexit uncertainty for pharmaceutical companies, Pharmig News, Issue 72, pp5-6

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Thursday 2 August 2018

New technical specification for auditors of ISO 45001

ISO 45001, Occupational health and safety management systems – Requirements with guidance for use, made standardization history when it was published in March this year. Now, a new complementary technical specification – ISO/IEC TS 17021-10 – has just been published, defining the required skills and knowledge of those bodies auditing organizations that have implemented the health and safety standard.

ISO/IEC TS 17021-10, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 10: Competence requirements for auditing and certification of occupational health and safety management systems, is intended to guarantee a harmonized approach to the accreditation of an ISO 45001 certification.

The new technical specification is aimed at auditors, or anyone making certification decisions related to ISO 45001, and will ultimately serve certification, accreditation and regulatory bodies by confirming that auditing and certification decisions related to ISO 45001 have been carried out by those who have the competence to do so.

Posted by Dr. Tim Sandle

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