Assisting an Analytical Testing Laboratory with US FDA Inspection

June 21, 2021
by SeerPharma

Chemika is an independently owned chemical analysis laboratory located in  Girraween, Sydney, and is licensed with the Therapeutic Goods Administration (TGA) and the Australian Pesticides and Veterinary Medicines Association (APVMA). Chemika provide chemical testing services to manufacturers of human therapeutics and veterinary medicine. Services encompass raw material and finished products testing as well as analytical support for process validation and product registration.

As a TGA licensed contract testing laboratory Chemika have been working towards obtaining US FDA accreditation by the first quarter of 2021. In response to this business requirement, Chemika engaged SeerPharma to help prepare the QC laboratory and staff for a future US FDA inspection, by requesting a mock audit of their operations focusing on the following FDA regulations and guidance:

FDA Regulations
  • 21 CFR Part 211, Subpart B, Sec. 211.22 Responsibilities of quality control unit
  • 21 CFR Part 211, Subpart I - Laboratory Controls
  • 21 CFR Part 11 – Electronic Records; Electronic Signatures
  • USP Reference Standards, Assays and Test Methods
Guidance for Industry
  • Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
  • ICH Harmonised Tripartite Guidelines:
    • Q1A(R2) Stability Testing of New Drug Substances and Products
    • Q2(R1) Validation of Analytical Procedures: Text and Methodology

Analytical Chemistry Laboratory

With over 20 instruments in the laboratory, including LC’s connected to a Shimadzu CDS, and a bespoke Laboratory Information Management System (LIMS), SeerPharma was tasked to conduct a compliance review/audit of QC laboratory systems against:

  • US FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures
  • US FDA 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals, Subpart I - Laboratory Controls
  • US FDA 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
  • PIC/S Guide to GMP for Medicinal Products Part I and applicable annexes with a focus on Chapter 6 Quality Control including a review of:
    • Organisation and Personnel
    • Facilities
    • Equipment
      • Equipment Design
      • Laboratory equipment calibration
      • Laboratory preventive maintenance
      • Equipment Validation
    • Testing Facilities Operation
      • Standard Operating Procedures SOPs for laboratory records, notebooks, worksheets and logs
      • Reagents, Solutions and reference standards (including labelling)
    • Test and Control Articles
      • Analytical Method Validation.
      • Control of stability studies
    • Records and Reports
      • Storage and retrieval of records and data
      • Retention of records
    • OOS (lab errors, investigations)
    • Training
    • A measure of the software controls involved in Data Management and Data Integrity (DMDI) against US FDA defined principles of data being Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available
    • Technical Transfer of Testing Methods
The review included documented practices and the adherence to the practices.

When reviewing the systems from a Data Integrity (DI) aspect, the focus was on:
  • System roles
    • What level of access should analyst, lab managers have?
    • Where should administrator access lie?
  • Access Control
  • Data Storage – raw data vs processed results; paper vs electronic; true copies; traceability links
  • Backup procedures
  • Qualification / Validation
  • Audit Trails
    • When to review?
    • How often to review?
    • What to review?
    • Who should review?

With COVID-19 travel restrictions in place, SeerPharma was able to conduct most of this audit and review remotely. Following the assessment, SeerPharma provided Chemika with a gap assessment report, identifying deficiencies that will need to be addressed prior to the regulatory inspection from the US FDA.

"SeerPharma provided to Chemika exactly what we required, with a very thorough review of our systems. The audit delivered deficiencies we were aware of and working to close, but more importantly identified areas where we were completely unaware where our systems needed to change significantly. Thankfully we found that overall we were pretty close to fully compliant, and are in an excellent position to meet our timeline for FDA registration."

Alan Doughty, Managing Director, Chemika

SeerPharma routinely work with clients across the APAC region in preparing them for regulatory (e.g. GMP) inspections from authorities such as the US FDA, TGA, HSA, Medsafe and EMA as well as audits from accredited bodies against ISO standards such as ISO 9001, ISO 13485 and ISO 17025.

Contact us should you require assistance in preparation for such inspections or audits relating to a licence or certification, or click here to learn more about our Auditing services.

Filed Under: FDA, analytical testing, laboratory