Compounding Pharmacy Services
Compounding pharmacies have seen a great deal of regulatory attention lately with FDA embarking on an aggressive inspection schedule is producing multiple 483 findings. Review of these
shows several common findings within the following topics:
- Procedures to prevent microbial contamination
- The Environmental Monitoring program
- Validation of the sterilization method
- Media Fill Simulations
- Control/cleaning/qualification of critical equipment used in manufacture
- Personnel gowning
- BUD not supported by stability data
- Laboratory procedures - especially USP <71> Sterility Tests
- Control of outsourcing services including contract lab services
- Issues with investigations of failures or complaints
- Batch release
- Control of incoming raw materials and components
Although USP <795>, <797>, and <1163> address these issues, the complex nature of the GMP requirements makes a compliant compounding pharmacy operation difficult to achieve. Let the GMP experts at Microbiology Network help navigate these issues.
Microbiology Network, Inc. can provide a variety of services to help the Pharmacist-in-Charge to maintain a productive, compliant and profitable pharmacy for the compounding of both sterile and non-sterile preparations. Take advantage of our Subject Matter Experts (SME) in a range of topics:
The experienced trainers at Microbiology Network can provide GMP or basic training in a variety of topics. With years of experience to share, let your employees learn from our staff.
Training can be either on-site at your facility, or via web-based training. All training programs are accompanied by documentation for your records. Select from training including focus on <795>, <797>, <1163> and specific test methodologies such as <71> Sterility Tests, <61> and <62> Microbial Limits Tests and <51> Antimicrobial Effectiveness Testing
- Review of Procedures
Having a fresh set of eyes review existing procedures can often help identify areas for improvement in a written procedure, or identify gaps in existing coverage. Once these opportunities are identified, the Microbiology Network SME can assist in addressing these needs in an efficient and economical manner. Particular areas of concern in today’s environment include procedures governing microbiological contamination control and microbiological laboratory testing (esp. <71> Sterility Testing).
- Review of Critical Controls
The safe and compliant preparation of compounded medications requires control of a variety of components. The Microbiology Network SME can help the PIC in this regard, both in reviewing existing measures for effectiveness and in recommending and implementing enhancements to critical compounding controls. Some of these critical controls recently highlighted by FDA review include:
- Facility Design and Air Handling (including requisite smoke studies)
- Utilities Control (water, compressed gases)
- Cleaning and Sanitization (equipment and facility)
- Environmental Monitoring and Data Trending
- Equipment Control
- Equipment Qualification – I/O/PQ
- Validation of Sterilization Process (or Media Fill for Aseptic Compounding)
- Audits of Contract Laboratory Services
The pharmacy is frequently at the mercy of contract laboratory services for technically demanding testing such as Sterility Tests (USP <71>), Bacterial Endotoxin Testing (USP <85>) Microbial Limits Testing (USP <61>, <62> and <1111>) and Antimicrobial Effectiveness Testing (USP <51>). Unfortunately this trust has not been rewarded in recent events. Let the SME at Microbiology Network assist your audit team in qualifying contract lab services and recommending improvements in existing services.
- Audits of Contract Compounding Services
Many pharmacies are not able to provide a full range of services and so are dependent on outsourcing for specific classes of pharmaceutical preparations. Recent events have shown that this practice carries a significant level of risk. Let the SME at Microbiology Network assist your audit team in qualifying compounding services and recommending improvements in existing services.
- BUD and Stability Studies
Determination of the appropriate design and extent of stability studies to meet the changing definitions of stability studies is confusing. The Microbiology Network has SME with years of experience in designing and coordinating these studies.
- Assistance with Regulatory Responses
Responding to FDA during the audit and after will have a significant impact on future relations with the Agency and can directly affect the bottom-line. Avoid adding unnecessary cost to regulatory compliance by involving Microbiology Network GMP experts early in the process to assist in effective regulatory strategies.
Let Microbiology Network, Inc. help prepare your pharmacy for the regulatory realities and maintain a state of compliance in a fiscally responsible manner.
Past Articles of Interest
- Sutton, S. 2014. FDA, USP, and the 503B Outsourcing Facilities J. GXP Compliance 18(2)
- Sutton, S. 2013. The Antimicrobial Efficacy Test, GMP and Investigations American Pharmaceutical Review 16(5):40-48.
- Grilli, A. 2013. Microbiology & Compounding Pharmacies: What the 483s Tell Us Contract Pharma.
- Sutton, S. 2013. The Contamination Control Plan in Facility Validation IN: Contamination Control in Healthcare Product Manufacturing RE Madsen and J Moldenhauer (ed) PDA/DHI Publications pp. 7-30 2013
- Sutton, S. 2013. Method Suitability Control Studies for Microbial Testing: Quantitative Comparisons. Journal of Validation Technology 17(2).
- Sutton, S. 2013. GMP and Compounding Pharmacies American Pharmaceutical Review 16(3):48-59.
- Sutton, S. 2012. Environmental Monitoring Data Trending in the Aseptic Core – USP <1116> and “Contamination Recovery Rates” Journal of GXP Compliance 16(4):59-63 2012
- Sutton, S. 2012. What is an “Objectionable Organism”? American Pharmaceutical Review 15(6):36-48.
- Sutton, S. 2012. The Contamination Control Plan in Facility Validation Journal of Validation Technology 18(2):42-47.
- Sutton, S. and L. Jimenez. 2012. A Review of Reported Recalls Involving Microbiological Control 2004-2011 with Emphasis on FDA Considerations of “Objectionable Organisms” American Pharmaceutical Review 15(1):42-57.
- Sutton, S. 2011. Sterility Tests IN Rapid Sterility Testing J. Moldenhauer (ed) PDA/DHI Publ pp 7-24.
- Sutton, S. 2011. Contamination Control in the Compliance Program. Journal of GXP Compliance 15(4):58-64. Awarded the Journal of GXP Compliance 2012 Paper of the Year.
- Sutton, S. and R Tirumalai. 2011. Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle. American Pharmaceutical Review May/June pp 12-30.
- Sutton, S. and D. Singer. 2011. Microbiological Best Laboratory Practices, USP <1117> – Value and Recent Changes to a Guidance of Quality Laboratory Practice with Don Singer. American Pharmaceutical Review 14(4):41-47.
- Sutton, S. 2011. Successful Microbiological Investigations American Pharmaceutical Review 14(2):34-42.
- Sutton, S. 2011. Successful Use of a Contract Microbiology Laboratory Journal of GXP Compliance 15(1):54-64.