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Frequently Asked Questions

What are the common quality problems in the industry?

Similar issues have plagued the industry for years: documentation, training, change control, out-of-specification (OOS) investigations, etc. If companies invested more time in evaluating the impact of these areas, they would save resources, avoid costly rework to product, and attain a better standing with regulatory agencies and clients..

A classic example of the proper quality philosophy is that the Quality group “owns” the production suites and does not release them to Manufacturing until all the appropriate documentation is complete, then the rooms revert back to ownership by the Quality group who can restrict both access and activity. This procedural check and balance provides a prospective review of any gaps in training, raw materials testing, environmental monitoring, cleaning, or procedural changes before they are implemented in production. The reverse of this philosophy is where production activity is largely unfettered by quality issues until after the batch is completed and the review and investigations of errors is handled with the ultimate goal of releasing the lot for market or clinical use. Such a mindset is not only corrosive to the overall quality assurance at a firm but it largely negates the preventive nature of a quality improvement program.

Do I need to perform internal audits?

Yes, it is a requirement to develop a self inspection process and information collected is reviewed by management so they are informed about the state of operations. Management should define corrective actions for issues and implement solutions for continuous improvement. Internal audits are a sign of a robust quality program at a company.

Beyond the regulatory requirements, it makes good business sense to know the deficiencies or problems within the organization before a regulatory authority inspects the company. A common problem is poor communication of changes (e.g., manufacturing, analytical, procedural, etc.) to the regulatory and quality groups, which may render the marketed product adulterated in the eyes of the FDA if it was made outside of the approved procedures and specifications in the application. Many firms have discovered this the hard way – after quarantine and shipment of marketed product or lengthy development studies to support the variation in production – that their ability to communicate change was vastly underestimated. Severe problems have resulted in consent decrees or Notice of Administrative Action that effectively superimpose a third-party quality assurance program on top of the company’s own.

Do we need to perform vendor audits?

On-site vendor audits will soon be a regulatory requirement. Even now, companies must ensure that any material purchased meets the regulatory standards and have a process to evaluate long-term consistency of all materials received. Some of the most notable cases of contaminated drugs stemmed from adulterated starting materials. So, it is essential to have assurance of the vendor’s quality programs as well as a robust analytical program to test incoming materials for purity, potency, and identity.

Why do we need a development report?

Drug development is a lengthy, multi-disciplinary coordinated effort. If the particular aspects of a program (e.g., analytical method development and validation, process optimization, formulation development, etc.) are not documented in a timely fashion, those data and history may be lost as team members move to different projects or companies. When the market application is compiled years later, those critical data and conclusions are often the only ‘bridges’ from one data set to another. Without them, these ‘islands of data’ become difficult to integrate into the whole program, thus complicating the utility of clinical trial material or stability data. The lack of demonstrated comparability from one process to another can cost the firm time and money to repeat something that could have been averted. Thus, it is imperative that firms take the time to document these activities as they occur.

Another critical aspect of having development reports in place is their essential use during the early phases of process development. Whether scaling up a process or optimizing one, the development report is often the only definitive summary for defined operating ranges or identifying steps with critical parameters (e.g., those that impact product purity or potency). The FDA expects to see an approved development report that contains a summary and conclusion. This document is important to develop process validation requirements.

Should we have a formal technology transfer process?

Yes. All steps needed for each process must be documented and defined. In order to achieve this, a formal technology transfer process is needed to share the knowledge, methods, and tools between the two sites or between R&D and Manufacturing.

For many of the same reasons outlined for development reports, technology transfer protocols and reports are often the only documented bridges from one company or group to another. The historical value of these reports and their place in the development program are often underestimated. Thus, there should be a formal quality assurance program within a firm to ensure these reports are generated and signed off in a timely fashion.

Why do we need a Quality Agreement?

Any companies engaged in business should have well-defined roles and responsibilities, requirements for production and communication, and quality standards. Such a collaborative effort between companies and their vendors is defined in such an agreement

Regulatory authorities expect a sponsor to integrate their quality procedures with any contract manufacturer or contract analytical firm’s own quality procedures. That is, it is simply not enough for a sponsor to accept the contractor’s services with a proviso that their quality systems replace yours. Too many times the FDA and other agencies have seen sponsors abrogate their quality responsibilities. But the contractor is not the sponsor of the application and their quality evaluation is only limited to a small or discrete portion of the entire program. In order to adequately assess the impact of any changes or manufacturing deviations, the sponsor must outline those criteria in the quality agreement so there is no misunderstanding among the parties as to who is ultimately responsible for when things go wrong.

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