Contract Laboratories Help Pharmaceutical Companies Respond to
Growing Demands
By Michele Piepoli
Of all the challenges that pharmaceutical companies face, managing a new product, from inception to finished product launch, is probably the toughest one they grapple with. Increasingly, more and more pharmaceutical companies are deciding not to go down this difficult road alone. They are turning to outside contract laboratories to outsource much of the intensive analytical and validation work to not only ease the burden, but to speed the process so they can meet the growing demands of the industry.
However, the relationship between the contract laboratory and the pharmaceutical company has changed dramatically over the years. Pharmaceutical companies are no longer just looking for a
laboratory where they can submit samples for analysis and get results, they are actively seeking
a "partner"
with whom they can develop an ethical, long-standing pro-active partnership. Once an alliance is formed, the two parties will work closely together to achieve their goal -getting FDA approval (where applicable) and making the final drug product available for the consumer.
Outsourcing covers a broad range of services. The pharmaceutical company's need may be long-term, short-term, project specific, or all of the above. The main benefit of hiring an outside laboratory is the technical depth contained under one organization. Outsourcing can eliminate the need for additional staff, facilities, and/or equipment. Many clients prefer to keep specific projects in-house while "outsourcing" those that are more detailed or complex.
For example, one large pharmaceutical company approached our firm about handling method development and method validation on a raw material and finished product that was extremely toxic. The initial requirement was that our facility be capable of handling this type of compound. After that was confirmed, this pharmaceutical company went through an intensive evaluation process to make sure that our laboratory was the right one for the job. Your company will need to go through the same process if you decide to hire an outside laboratory.
The next step for this company was to conduct an on-site evaluation of our laboratory. During this critical stage, the company assessed our ability to meet their analytical needs and also verified that all analyses would be performed in accordance with cGMP regulations. Their goal was not only to review our facility's SOPs, but also to get a "feeling" about the technical quality of our laboratory.
The following key elements of the processes should be evaluated to determine if the contract laboratory is a viable partner for this pharmaceutical company:
 | Sample Management |
| Traceability |
| Sample integrity |
| Sample deposition. |
| Calibration Assessment |
| IQ/PQ |
| OQ/PQ |
| General calibration |
| Log books |
| Maintenance |
| Reference Standards |
| Storage |
| Labeling (must be consistent) |
| Qualification |
| Reagents and Solutions |
| Consistent preparation |
| Standardization |
| Analytical Methods |
| How are methods validated? |
| What is the process for transfer of methodology? |
| Staff |
| Employee training records |
| Curriculum vitae |
| Documentation |
| Out-of-specification (00S) protocol |
| Archival of records |
| Handling of raw data. |
Once our laboratory became "partners" with this pharmaceutical company, we initiated method validation protocols and determined what additional resources would be needed in order to achieve their goal. Each method was developed and validated as defined by the client. A final "method validation
report" was issued and an official "test method document" was generated. It was decided that our laboratory would perform all subsequent analyses, so a method transfer was not necessary.
Our facility began this work three years ago and throughout that time performed analyses as per the validated methods, as well as USP Compendial analyses. Recently, a
PAI (Pre-Approval/Inspection) was performed at our facility by the FDA regarding all analyses related to this specific compound. After a detailed evaluation of the data generated by our laboratory, the segment that we were working on in conjunction with our client was approved. This moved them one step closer to full FDA approval and marketing of the final drug product. Our laboratory continues to work closely with this company to monitor their batch manufacturing and perform analyses on their final drug product.
Another example of how a contract laboratory like ours works with a pharmaceutical company to bring a drug product to market involves a company that needed assistance in developing method of analyses for raw materials to determine and verify its quality. Our laboratory was hired to develop and fully va1idate over 25 methods.
These methods involved the use of high pressure liquid chromatography, gas chromatography and wet chemistry techniques such as titrations, viscosity,
and refractive index.
The time line was very short, but our laboratory was able to meet the deadline. The client was then
in a position to do pilot runs for evaluation
of a finished product. Our facility worked with this company every step of the way. More times than not, we all felt as if we were one company. This is a typical scenario and it was very exciting to be in partnership with this pharmaceutical company.
There were many pilot runs, feasibility lots, and launch lots and our laboratory verified the quality of the product during each phase. This particular situation also involved a very detailed method transfer. However, the responsibility does not stop at the point of transfer. Our staff was involved in numerous conference calls to assist in a smooth transition process.
From inception to final product on the shelf took approximately two years. It was particularly rewarding to see the final product in the market since our laboratory helped foster its development from the very beginning.
The relationship between the contract laboratory and the pharmaceutical company is an important
one. Once you've ensured that all of your analytical and regulatory needs can be met, focus on finding a laboratory with a high level of integrity, trust, and technical excellence. In the end, both partners' dedication to creating a beneficial alliance is what drives long-term success.
Michele Piepoli.
2000 Outsourcing Reference Guide
www.pharmpro.com
Pharmaceutical Processing
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