Why Validate?

The Pharmaceutical and Medical Device industries have many national and international regulatory requirements that they must satisfy to ensure that they are allowed to continue to manufacture and sell their products.

Satisfying the regulatory commitment is a very expensive process. All Pharmaceutical and Medical Device companies invest a large proportion of their operating budgets simply satisfying these regulatory requirements.

Validation is part of these regulatory requirements. The FDA defines validation “as establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.

Simply put, this means to prove that a process, system or equipment will do what it is designed to do time after time every time.

Each Pharmaceutical or Medical Device manufacturer must validate its process and equipment before they can accept commercial sales.

What is Validation?

Since the Mid-1970s, Validation considerations have played an increasingly dominant role in the manufacture and quality assurance of U.S. health care products. But the origins of validation in the United States goes back to 1906 when the Food and Drug Administration (FDA) was formed in response to, of all things, a book!

The book, called “The Jungle”, written by Upton Sinclair depicted conditions in the Chicago meat markets that were so bad that Americans cut their meat consumption by over 50%.

This book had a dramatic effect on public opinion. Unfortunately, the conditions that the book described were not exaggerated and many people died from diseases they contracted as a direct result of the conditions under which their meat products were prepared and stored.

At the same time, Joseph Heinz (of the “57 varieties” fame) was busy lobbying the US Congress to pass laws governing conditions within food processing facilities. Mr. Heinz was a very responsible employer who provided his employees with excellent working conditions and benefits including one of the first company pension plan ever to be established. He also insisted that all processing areas be maintained to a high standard of order and cleanliness.

The public outcry over the book and the ensuing drop in meat sales was comparable to the recent “Mad Cow” scare in the UK. This, coupled with the incessant lobbying of Joseph Heinz prompted then President Teddy Roosevelt to persuade congress to pass the first Food and Drug Act.

In 1962, the FDA issued a first set of Good Manufacturing Practices (GMP) for the Pharmaceutical and Medical Device Manufacturers as a means of assessing the quality procedures and practices of a company.

This came as an after effect of the Thalidomide incident. Clinical testing of products prior to commercialization was introduced and any potential side effect now had to be disclosed to physicians as well as to the general public.

The 1962 GMPs delineated guidelines on how to produce, package, store, market, and distribute Pharmaceuticals and Medical Devices.

Finally, in 1976 the FDA proposed a whole new set of current Good Manufacturing Practices (cGMP’s). After three years or so of public hearings as part of “due process” to convert the new regulations into law, these proposals were declared substantive, which meant that non-compliance with the new regulations had now become a prosecutable criminal act.

It is important to keep in mind that the FDA is an enforcement agency. Their representatives are called “investigators” not inspectors. They have the authority to ask for any record they feel may be pertinent to an audit or a review they are carrying out and they don’t mind flexing their muscles to obtain what they want.

Today, all industrialized nations have similar government bodies that act as the FDA acts. In fact most of the worlds regulatory agencies have very similar regulations and requirements.

All our customers are therefore required by law to conform to the cGMP’s as they apply to their specific processes and products. And just as importantly, they must prove product purity, safety, efficacy, and consistency… How does all of this tie in to Validation? Well, simply put, validation or proving that the system or equipment will do what it is designed to do time after time every time will ensure product purity, safety, efficacy, and consistency.

Who is responsible for Validation?

Ultimately it is up to the manufacturer of any Pharmaceutical or Medical Device product to prove that their products and processes are safe. After all, they are the ones making and selling these products.

They do so by documenting then systematically challenging and testing the methods and practices that they employ to produce their products.

Failure on their part to comply with the cGMP’s, or more accurately failure on their part to provide evidence of compliance with the cGMP’s can result in one or a combination of several sanctions. These include suspension of commercial licenses (it is difficult to generate profits when you are not allowed to sell a product), costly legal cases and financially damaging product recalls or delays. And, in severe cases compulsory plant closures until the problems are addressed.

The FDA can also prosecute individuals who willingly contravene the regulations and although rare, individuals may be subject to imprisonment if convicted. The FDA also has the power to ban convicted individuals from employment by any pharmaceutical company with interests in the USA.

What is important here is that evidence of compliance must be available. This means written records must exist for just about everything.

Our clients are required to document in great detail what they need (Functional Requirements Specifications), what equipment suppliers provide (Detailed Design Specifications), (design and programming written procedures), (complete and detailed Machine Manuals with all third-party technical documentation), and proof that the equipment will operate as expected (Factory Acceptance Testing) time after time every time (Validation).

SMB Group serves three major markets: The Pharmaceutical, Medical Device and Biotechnology manufacturers or PMDB industry and the Equipment Designers and Builders that are suppliers to the PMDB industry. Additionally training opportunities exist for those individuals who wish to enter or stay current within the PMDB industry.

1. The primary target market encompasses all PMDB Manufacturers and their immediate subsidiaries that are subjected to FDA and other similar regulations as well as some of their major direct suppliers. Laws & Regulations in this targeted market are becoming more and more stringent and will result in the compliance functional units of PMDB manufacturers having to meet ever-increasing requirements.

The services of SMB Group are based on USFDA regulations. Many PMDB Manufacturers wish to apply a consistent standard to all their installations regardless of their actual geographical locations. The FDA regulations being generally recognised as the most exacting in the world, they are frequently selected as the reference standard. Moreover, with continued development of new biotechnologies, the target market is continuously expanding. New Biotech companies are continually created. Most Biotech companies are purposely maintained as relatively small business entities in order to minimise the risk in the event of a catastrophic adverse event that could literally “sink” the company. Because of their relatively small scale, many of these, if not most, are not staffed with all the traditional disciplines.

2. The second target market for SMB Group consists of the numerous Equipment Designers/Manufacturers and Distributors that are suppliers to the PMDB industry. With the shrinking of internal support staff within the PMDB industry alluded to above, the industry is turning to the Equipment Designers and Builders to provide more extensive documentation than has traditionally been the case. Requests for quotation from PMDB customers now typically include requirements to provide Detailed Design Specifications as well as other similar support documentation. Most Equipment Manufacturers are ill prepared to deal with such requirements and risk not being seriously considered by the PMDB manufacturers when they seek production and packaging machinery.

3. The third strategic market targeted by SMB Group will consist of providing training programs for individuals who wish to enter the PMDB manufacturers market or who wish to further develop their knowledge of the PMDB industry and, as mentioned above, for the personnel employed by equipment manufacturers and distributors.

Another field of opportunity lies with cGMP training for the engineers, designers and sales representatives of equipment manufacturers. Adequate cGMP training will enable the engineers and designers to better understand the requirements of their customers and thus provide equipment better suited to these needs. Similarly, the equipment distributors’ sales representatives can benefit from this type of training and hold more productive discussions with their customers by being able to “speak the same language”.

Why should I choose SMB as our validation provider?

SMB Group has a distinctive expertise in:

• Pharmaceutical and Medical Devices validation regulatory compliance
• Equipment Design and Construction
• Validation documentation
• Validation implementation
• Pharmaceutical production and packaging
• Pharmaceutical production environment and physical facilities
• Operator and Maintenance personnel training
• Quality auditing

This experience provides for a competitive advantage other validation providers. It is the firm belief of the SMB Group that few equipment suppliers employ personnel that offer the training and experience of SMB Group. On the other hand, few professional providers can profess to possess an equally in-depth knowledge of equipment design and assembly as SMB Group does. Therein lies the competitive edge; SMB Group can offer a wider range of services than the competition along with significant practical “hands on” experience both from our customers’ perspective as well as that of the regulatory agencies.