Benefits of Effective Communication with a Contract Analytical Laboratory - How to handle out-of-specification results in contract analytical work. - BioPharm International

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Benefits of Effective Communication with a Contract Analytical Laboratory
How to handle out-of-specification results in contract analytical work.


BioPharm International Supplements


Abstract

The contract analytical laboratory (CAL) plays such a key role in the support of its clients that the quality of communication between the CAL and client is arguably just as important as the quality of the science in supporting the production of biopharmaceuticals. Communication is just as important when out-of-specification (OOS) results arise. It is always to the manufacturer's advantage if the CAL has the resources, back-up, and communication channels available to provide an assured service when results are OOS.


RSSL Pharma
For any biotech company considering using a contract analytical laboratory (CAL) to support its product development or manufacturing, the science on offer must be of the highest standard; the laboratory must be competent to carry out all of the analytical procedures required.

Analytical competence, however, is only one part of the story. Communication is extremely important in supporting the production of high-quality biopharmaceuticals. This is especially true when the results of an analysis indicate a problem with the product, as in the case of out-of-specification (OOS) results.

Pre-Analysis

Having identified a suitable partner laboratory, the first point of communication between the manufacturer and the CAL should be with the latter's quality assurance unit. This will be to ascertain the quality standards in operation, to receive copies of the letters of approval from the MHRA or the FDA, and to view at first hand the laboratory's facilities, not just for carrying out analysis, but also, for example, for receiving, storing, and disposing samples.

Assuming the CAL has the necessary quality systems in place, the discussions should focus on agreeing on the contents of a confidentiality agreement and technical agreement. The CAL is likely to have many other clients, so the manufacturer may wish to establish how potentially sensitive information will be protected from other companies' auditors. Confidentiality agreements may be prepared by the manufacturer or by the CAL, but in either case, must be agreed on by each party.

In Europe, EU Directive 2003/94/EC (the so-called "Orange Guide") makes it clear that a written contract is needed to define duties and obligations between the parties for good manufacturing practice (GMP) analysis. It is arguably impossible for a contract to cover every eventuality, but the more detailed the contract, the better. Nonetheless, the inspection authorities in the UK have noted, for example, that the contract should not only indicate that the laboratory will inform the client of OOS results, but also state how and when the results should be notified. Similarly, the contract would not only state that samples should be disposed of, retained, or returned, but also would specify how and within what period of time.

Either party may prepare the technical agreement. A CAL-prepared agreement often takes a generic approach to analytical testing, whereas manufacturer-prepared agreements are more likely to be written to cover specific analyses on specific products.

Regardless of authorship, both parties must check the contents of any agreement closely, because not all demands that are sensible in theory are actionable in practice. For example, the manufacturer may ask for the destruction or return of all documents, records, and data that belong to them. However, with the dependence of the modern laboratory on IT systems that are backed up every day, the destruction (i.e., deletion) of electronic records is a nearly impossible task. Understanding and accepting the requirements and limitations of both partners from the outset is critical for maintaining a good working relationship in the long run.

Analysis

Although contracts form the structure of the communication, and the legal basis for carrying out work and resolving disputes, true communication is a two-way activity. Both sides should feel comfortable requesting information from each other. The client can help the CAL by sending as many details as possible with the sample to be analyzed. Safety data sheets should be sent where appropriate, with details of the testing requirements and disposal instructions. From the laboratory's perspective, it is always better to receive too much information rather than too little, yet it is surprising how often clients appear comfortable sending samples with the simple, but inadequate, instruction "for testing."

That said, the CAL should be flexible and ready to receive sample information in electronic or paper format. Many CALs can copy data from a spreadsheet into a laboratory information management system (LIMS), or have a standard sample submission form available. When such a form has been designed by the CAL, it can be expected to request all the details the CAL needs. If the CAL does not have a form, then it should be suggested that it creates one.

When Problems Arise

Good communication is most important on the few occasions when an analysis does not progress as planned. These occasions can be broadly divided into two main categories: a deviation from the agreed methodology or an OOS result.

The technical agreement often will reference the methodology and procedures to be followed for the requested analysis. Hence, a deviation is defined as "a departure from an approved instruction or established method." The CAL should have a "deviations" standard operating procedure (SOP) to be followed in such circumstances.

However, deviations from methodology must be accepted and approved by the customer before starting the analysis. The laboratory must discuss the deviation with the client and provide evidence to validate that the deviation is appropriate. Such deviations should be detailed on the test report.

If the deviation is to a customer method, and is to become permanent, then a change control process needs to be instigated. The change control process should also be documented in an SOP. The change can then be validated by submitting analytical data to the client with a copy of the draft new method for after review, the client must provide documented approval that the change provides an improvement to the method.


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