OUTSOURCING CONSIDERATIONS
Table 3. Element Purpose Background Roles and Responsibilities Description Packaging Storage Conditions Number of Samples Aliquoting Test Frequency/Intervals
Test Methods and Specifi cations Testing/Data
Data Reporting
Simultaneous studies are often performed; therefore, careful thought should be given to finding a balance between batching efficiency and unrealistic sample volumes. Other considerations such as freeze-thaw logistics should be covered in the protocol as well. Further, studies performed in support of development and clinical trials may have different objectives than those for marketed products, and these differences need to be considered. Photostability, stress stability, and thermal cycling are all typically covered in a comprehensive program, and therefore, the contract organization should have experience with these types of studies. The development of a stability protocol is ideally carried out in a collaborative manner between the laboratory and sponsor.
Lastly, as important as the capability, capacity, and stability protocols are to the project, strong project management is paramount. Large stability programs can be logistically challenging and require a tremendous amount of planning, forecasting, scheduling, follow-up, and communication.
Regular
calls and meetings between the sponsor and the lab are crucial at least in the lead up and during the early time points of a study. A well- run meeting should be agenda-driven and followed up with minutes and action items in a timely manner. Key discussion topics include: planning for upcoming pulls, sample status, OOS results, “anomalous” results, investigations, and reference standards management. A proficient project manager must be able to effectively interface with
7 American Pharmaceutical Review | Biopharmaceutical Supplement 2014 Description What is the intent of protocol?
What is the product, and why is the study being performed? Who is responsible for which aspects of the study?
What is being stored/studied (ie, Reference Standard, Drug Substance, and Drug Product, including lot numbers)? Some studies may encompass diff erent strengths, formulations and/or products from diff erent bioprocesses.
What are the various packaging types and confi gurations (horizontal/inverted or upright)? What are the storage temperatures and tolerances?
How many samples are to be put in storage? Matrixing and bracketing designs may be used to reduce the number of samples. What retain and contingency samples will be stored?
How will the samples be aliquoted to minimize use and freeze-thaw cycles in order to perform all testing? When will the samples be pulled, and what are the tolerances? What method will be used and what are specifi cations?
What is the time frame from sample pull to testing, and how are OOSs handled? How will the data be reported?
the various testing laboratories, Quality Assurance, stability storage, and the sponsor. Therefore, the laboratory should have a proven track record in managing biologics stability programs.
References 1.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Stabilty Testing of New Drug Substances and Products Q1A(R2). February 6,
2003. Available at:
http://www.ich.org/fi leadmin/ Public_Web_Site/ICH_Products/Guidelines/Quality/ Q1A_R2/Step4/Q1A_R2__Guideline.pdf. Accessed August 27, 2014.
2. International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products Q5C. November 30, 1995. Available at:
http://www.ich.org/fi leadmin/Public_ Web_Site/ICH_Products/Guidelines/Quality/Q5C/ Step4/Q5C_Guideline.pdf. Accessed August 27, 2014.
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