Compounding Pharmacies and the Contract Testing Lab

Transcription

1 Compounding Pharmacies and the Contract Testing Lab Scott Sutton, Ph.D. 1 Disclaimer I am making this presentation as an independent agent I am not making this presentation as a representative of USP, PDA, PMF, SCA or any other organization with which I am currently associated. The views expressed in this presentation are offered as mine alone Microbiology Network, Inc. 1

2 Webinar Outline Who Cares? Documents of Use What to Look for in Picking a Contract Lab Conclusions 3 Frequent 483 Citations - Current 85 Reports 4/18/ Microbiology Network, Inc. 2

3 503B Registrations 38 as of 4/23/14 22 have been inspected All inspected have been issued 483 observations 5 have been issued Warning Letters issued 12/20/ Microbiology Network, Inc. 3

4 483 Issued 4/17/ Issued 1/9/ Microbiology Network, Inc. 4

5 483 Issued 3/20/ Issued 3/6/ Microbiology Network, Inc. 5

6 483 Issued to Lab #1 (11/8/12) Issued to Testing Lab # Microbiology Network, Inc. 6

7 483 Issued to Testing Lab # Issued to Lab #2 (11/13/12) Microbiology Network, Inc. 7

8 483 Issued to Testing Lab #2 (cont) Issued to Testing Lab #2 (cont) Microbiology Network, Inc. 8

9 483 Issued to Lab #3 (6/17/13) Issued to Lab #3 (cont) Microbiology Network, Inc. 9

10 483 Issued to Lab #3 (cont) Issued to Lab #4 8/30/ Microbiology Network, Inc. 10

11 483 Issued to Lab #4 (cont) Issued to Lab # Microbiology Network, Inc. 11

12 FDA URL References Reports perationsandpolicy/ora/oraelectronicreadingroom/ucm htm Reports perationsandpolicy/ora/oraelectronicreadingroom/ucm htm 503B Registrations macycompounding/ucm htm 23 Webinar Outline Who Cares? Documents of Use What to Look for in Picking a Contract Lab Conclusions Microbiology Network, Inc. 12

13 Documents of Use USP <1163> Quality Assurance in Pharmaceutical Compounding USP Chapter <1117> Best Microbiological Laboratory Practices ISO General Requirements for the Competence of Testing and Calibration Laboratories PIC/S PI Aide-Memoire: Inspection of Pharmaceutical Quality Control Laboratories 25 USP <1163> Quality Assurance in Pharmaceutical Compounding Section on TESTING Guidance on in-house testing and testing at contract labs Selection of a Test Method Sampling Requirements Storage Requirements Data Interpretation Requirements Personnel Requirements and Considerations Microbiology Network, Inc. 13

14 USP <1117> Importance Aspects of Control - Microbiology Aseptic Technique Control of Media Control of Test Strains Control of Equipment Lab Lay-out and Operations Sample Handling Microbiological Media Incubation Times Training of Staff Laboratory Resources Control of Data and Documentation Interpretation of Results 27 ISO Scope References Terms and Definitions Management Requirements Technical Requirements Annex A Cross-reference to ISO 9001:1994 and ISO 9002:1994 Annex B Guidelines for Establishing Applications for Specific Fields Microbiology Network, Inc. 14

15 ISO Management Requirements Organization Quality System Document Control Review of requests, tenders and Subcontracting of tests and calibrations Purchasing services and supplies Service to the client Complaints Control of nonconforming testing and/or calibration work Corrective action Preventive action Control of records Internal audits Management reviews 29 ISO Technical Requirements General Personnel Accommodation and environmental conditions Test and calibration methods and method validation Equipment Measurement traceability Sampling Handling of test and calibration items Assuring the quality of test and calibration results Reporting the results Microbiology Network, Inc. 15

16 PIC/S Guidance - PI Aide- Memoire: Inspection of Pharmaceutical Quality Control Laboratories (9/07) Purpose The purpose of this document is to provide guidance for GMP inspectors to assist in training and preparing for inspections. Scope This document applies to laboratories for testing of the finished medicinal products, intermediates, starting materials for the production of medicinal products and in-process controls PIC/S Guidance - Organization General information Quality Assurance System Documentation system Personnel Premises and Equipment Materials and Supplies Sampling and Samples Testing Results and Release of Test Results Supplements No.1: GMP inspection in chemical and physical-chemical laboratories No.2: GMP inspection in microbiological laboratories Microbiology Network, Inc. 16

17 PIC/S Audit guidance in table format The AIDE MEMOIRE in Annex consists of 9 tables containing general subjects and items to be investigated during the GMP inspection of laboratories. Some important questions and relevant references to the PIC/S documentation are included as well Webinar Outline Who Cares? Documents of Use What to Look for in Picking a Contract Lab Conclusions Microbiology Network, Inc. 17

18 What to Look for - Communication Good communication practices documentation Inform of issues in testing Reference ISO What to Look for - Openness Audit the lab Cannot perform a technical audit over the phone or by questionnaire Trust but verify Audit should allow complete access to documents and facility except to protect confidentiality of other clients Microbiology Network, Inc. 18

19 What to Look for - Documentation Can you confirm adherence to test method from documentation? Are failures trended (sterility, potency, etc)? Will you be receiving raw data with report? How are lab errors handled? How are investigations handled? Does the lab have a strong Quality Assurance Unit? Evidence? 37 What to Look for - Personnel Are separate chemistry and microbiology Subject Matter Expert (SME) identified? Are the SME qualified from academic and professional perspective? Are there sufficient people to service the workload? Are they adequately and regularly trained? Microbiology Network, Inc. 19

20 What to Look for Sample Handling Is a clear chain of custody established for incoming samples through reporting? Are samples stored appropriately? Are samples testing promptly? What metrics are available? 39 What to Look for Reagents and Supplies How are suppliers for the lab approved and tracked? How are materials prepared/acquired, tested for acceptability while quarantined and then release for use? How are expired materials removed from use? Are the appropriate materials being used for the specific tests? Microbiology Network, Inc. 20

21 What to Look for Lab Layout Lab area should be out of traffic Sufficient electrical supply, lighting, environmental control (temp, humidity) Microbiology lab should be open, clean with sufficient handwashing stations Good repair, easily cleanable 41 What to Look for - Equipment Qualified (IQ / OQ / PQ) reference USP <1058> Under preventative maintenance agreement (PM) Monitored to document state of control (logbooks or electronic monitoring) Appropriate to the testing Sufficient to the need Microbiology Network, Inc. 21

22 Webinar Outline Who Cares? Documents of Use What to Look for in Picking a Contract Lab Conclusions 43 Conclusions If it isn t written down, it didn t happen Trust but verify The work performed at a contract lab is yours It is on your product You are paying for it Your license may depend on its quality KNOW WHAT IS BEING DONE IN YOUR NAME Microbiology Network, Inc. 22

23 Thank you to our Sponsor Further Reading Daniells, S Experts Outline 7 Seven Basic Tips for Selecting a Contract Laboratory: HerbalGram article Sutton, S Successful Use of a Contract Microbiology Laboratory J GXP Compliance 15(1): Wertalik, PL. Selecting Contract Laboratories Carter-Hamm, B and G Vinson Facilitating Client Audits - The Contract Laboratory Perspective Pharm Technol Outsourc Res 2002 pp /27691/article.pdf Microbiology Network, Inc. 23

24 Upcoming Webinars May 22 nd - Compounding Pharmacies and the Bacterial Endotoxin Test June 26 th - Compounding Pharmacies and Sterilization / Media Fills 47 THANK YOU FOR YOUR ATTENTION QUESTIONS? Scott Sutton, Ph.D. scott.sutton@microbiologynetwork.com (cell) Microbiology Network, Inc. 24