GCLP Tenets on Activities, Paperwork and Personnel

| Tuesday, September 6, 2011
By Geoffrey Paine


The Good Clinical Laboratory Practice or GCLP is a set of standards that every medical organisation that are handling clinical and laboratory tests must stick to.

Right now, the GCLP Guidelines is composed of many various divisions and departments. Each one of those are vital and each member of your team must be informed of the varied GCLP Guidelines that concern them.

Here is a high level view of 3 divisions in your organisation that can be found on the GCLP Guidelines.

GCLP Guidelines on Activities

Some of the activities included in the GCLP Guidelines would include conducting initial GCLP trainings for all new workers, regular competency assessments.

Any other activities in the organisation that is somehow relating to the GCLP Guidelines must be documented.

It's also critical that all activities are recorded and documented in the event of a GCLP audit.

GCLP Guidelines on Paperwork

One of the most vital parts of GCLP, each organisation participating in the GCLP must have the following documents in storage and all must be readily available for evaluation:

1. Organizational, departmental, and/or personnel policies (orientation, training, continuing education necessities, performance analyses, benefits, discipline, dress codes, holidays, security, communication, termination, and attendance)

2. Job descriptions that identify qualifications and delegation of obligations for all laboratory positions

3. Staff files that document each employee's qualifications, training, and competency assessments as they relate to job performance

4. Organizational chart (s) that represent the formal reporting and communication relationships that exist among personnel and management and between the main lab unit and satellite units



There should additionally be manuals or written Standard Operating Procedures (SOP) that'd be used to determine an organisation's consistency, quality and integrity. This manual must contain a catalogue of the different procedures, forms and other related documents employed in the hospital or in the lab.

GCLP Tenets on Staff

Albeit, a lot of what is in the GCLP Guidelines is related to the staff. This is comprehensible since it is truly the workers who are handling the numerous examples that are brought to the lab or hospital.

According to the GCLP laws, each laboratory must have an elected member of the team who will act as the officer in charge. This person is the single point-of-contact for anything that's related to document controlling, staff coaching and data on GCLP rules and rules.

As discussed earlier, each member of the team must be given the right coaching and regular appraisal of talents and performance.

It's also necessary for personnel to make sure that all of the bits of kit are in the manufacturer's specs. There should be preventive upkeep for these items of equipment both internally and outwardly (vendor-provided services).




About the Author:



0 comments:

Post a Comment