CMO
• Risk-free compliance has a price • CRO/CMO selection and set-up creates lag time • CRO/CMO management and governance can be resource-intensive
• Sponsors, CROs, and CMOs may undergo a merger or reorganization, leading to a loss of team members and knowledge or a change of focus
• Many of the decision makers are risk-averse in a risk-based climate/business
• Regulatory requirements, GxP compliance, and quality, in particular, are becoming increasingly more complex
Traditionally CROs/CMOs are chosen based on: • Reputation/word of mouth • History of working relationship • Cost effectiveness, price, and affordability • Ability to supply product at an acceptable cost/dose • Speed of execution to decrease time-to-market • Experience with similar products • Regional knowledge
• Availability of facilities/services/staff not otherwise available in-house
• Adoption of virtual pharma model by small-size to mid-size companies, biotech, and specialty pharma
• Scientific capabilities ·
Complex and specialized technical competency/skills; capabilities (eg, high potency, biologics, etc) which are not available in-house
• Years in business and years performing the relevant service • Location
What Is the Role of Quality Assurance in
Selecting a CRO/CMO? Quality Assurance (QA) can play a fundamental role throughout the life cycle of any GxP-related outsourcing partnership.
After the screening stage, QA can conduct a qualification audit (ie, due diligence) of the few finalist contenders with the aim of verifying the critical parameters (eg, quality, compliance, etc) stated in the completed screening questionnaire, Request for Information, and Request for Proposal.
There are also numerous advantages for a QA audit/review of the contract, although this is not always done. A QA audit of the contract is primarily done to help ensure compliance with the applicable GxP requirements. Additionally, important issues may be identified during the previous stage (the qualification audit) that may need to be stated in the contract. For example, a QA review may indicate a need to include a clause/condition in the contract that any qualification issues must be resolved prior to a set date (depending on the criticality and impact).
An effective QA function of the contracting pharma company substantially relies on many tenets such as the anatomy of the function itself (eg, its position within organization/authority, Quality Management System [QMS], qualification and experience, etc) and
physiology (an effective risk-based audit program, good auditing practices, standard operating procedures [SOPs] on key aspects of auditing, corrective actions and preventative actions [CAPA] trending and effectiveness evaluation, behavioral aspects, etc). The effectiveness of a QA audit program depends on whether it has been designed to take into consideration key factors such as the status and importance of the processes and areas to be outsourced. A QA audit should provide an independent evaluation of quality as well as bring a fresh perspective and new insights to the process. The methodologies and schedule should identify potential problems (and find solutions) before it is too late; a post-mortem only identifies the reason for the death; it does not repair the effects of a fatal flaw. Evidently, to afford the above infrastructure and effective functionality, the internal QA needs to have the right caliber and expertise. If the internal auditor lacks the required expertise, contracting external auditors with the required level of expertise is worth the investment.
Qualification Visit/Audit: What Does QA
Consider During the Selection Process? This visit should be a team with representatives from both operational and QA departments. QA’s main objectives during the selection process are to verify the provider’s:
• QMS
• Relevant GxP compliance with applicable GxP regulations and quality standards and inspection history (if known)
• Competence to deliver the service • Capacity to meet service demand and any potential variations
· · ·
Ability to supply a service at acceptable quality while meeting timelines
Secure business capable of long-term supply, invests in up-to-date technology
Commitment to sponsor’s business, ie, not de-prioritizing due to new businesses
• Infrastructure and quality culture ·
· CRO’s/CMO’s physical assets and capability Scalability of the facility/organization
• Facility’s/organization’s delivery metrics • Experience with drug development • Anticipated contract terms
• Specific strengths, eg, sometimes suppliers that focus primarily on commercial GMP production do not excel in clinical GMP ·
Their processes may be too heavy and slow to accommodate the changing needs of clinical manufacture
·
Such companies often lack essential analytical equipment (high-performance liquid chromatography, tandem mass spectrometry, nuclear magnetic resonance, etc)
Pharmaceutical Outsourcing | 16 | March/April 2015
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78