What Steps Are Involved in Becoming a DAMAS Laboratory?

There are three steps involved in becoming a DAMAS certified laboratory as explained in the following paragraphs. Step two assumes that you choose to use the services of a consultant. You may prefer to attempt the preparation of your own system. This is, of course, possible. However, experience shows that achieving compliance in this way is usually very long, time consuming, expensive, frustrating and most often unsuccessful.  The consultant knows the ins and outs.

One of the three main reasons for achieving DAMAS certification as stated in an earlier part of this series, is to satisfy the obligatory GMPs detailed in the FDA document CFR Part 820.  Once again the consultant has the necessary knowledge to ensure these requirements are fully satisfied.

The first step in becoming a DAMAS certified laboratory is to contact the NADL and request an information pack.

The second step is to contact Lawrence-Hall Consultants Ltd, SafeLink, Inc. or another consultant to arrange a convenient date for a consultant to visit your laboratory. Most likely, the consultant will ask for a guided walk through the laboratory with the owner or a technician able to explain in very general terms the processes involved. This is followed by an explanation of both the DAMAS system and the FDA regulation. From this point on the consultant will want to talk to various people for the purpose of preparing the DAMAS system.

During his or her visit, the consultant will discuss with the relevant staff members recommendations for amendments or modifications to the existing systems; whether these are accepted is of course your decision. If modified systems are introduced the consultant will assist in their implementation including any staff training that may be required. After the on-site visit he may ask to contact you for further information etc. by telephone or e-mail.

The consultant will prepare the final system as a hard copy quality manual together with a procedures manual including the detailed system requirements necessary to achieve certification. The consultant will be prepared to visit you again at your convenience to ensure the systems are satisfactory and running smoothly. He can always be contacted and will be ready and willing to offer further help and advice.

The third step is to contact the registration authority to make application for certification. This occurs once the system has been in place for a minimum period of three months. The consultant can make arrangements for this on your behalf. The registration authority arranges for their representative to visit you, when he will spend a day checking the contents of the system and verifying its effectiveness. Once again, should you so request, the consultant can be present to assist at this time. You then receive a certificate of registration that confirms your status as a certified DAMAS laboratory.