GCLP Guidelines on Activities, Documentation and Personnel

| Tuesday, September 6, 2011
By Geoffrey Paine


The Good Clinical Lab Practice or GCLP is a collection of standards that each medical organisation that are handling clinical and lab tests must adhere to.

At this time, the GCLP Guidelines consists of many alternative divisions and departments. Each one of these are very important and every member of your team must be made aware of the various GCLP Guidelines that concern them.

Here is a top level view of three divisions in your organisation that may be found on the GCLP Guidelines.

GCLP Laws on Activities

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

Any other activities in the organisation that's somehow in relation to the GCLP Guidelines must be documented.

It is also vital that all activities are recorded and documented in case of a GCLP audit.

GCLP Guiding principles on Documentation

One of the most crucial parts of GCLP, each organisation collaborating in the GCLP must have the following documents in storage and all must be freely available for evaluation:

1. Organizational, departmental, and/or staff policies (alignment, coaching, continuing education wants, performance evaluations, benefits, discipline, dress codes, vacations, security, communication, termination, and attendance)

2. Job descriptions that define qualifications and delegation of commitments for all laboratory positions

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

4. Organizational chart (s) that represent the formal reporting and communication relations which exist among staff and management and between the key laboratory unit and satellite units



There should also be manuals or written Standard Operating Procedures (SOP) that would be used to gauge an organisation's consistency, quality and integrity. This manual must contain an inventory of the numerous procedures, forms and other related documents used in the clinic or in the laboratory.

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 mentioned earlier, every member of the team must be given the right training and regular assessment of abilities and performance.

It's also required for personnel to be sure that all of the pieces of equipment are in the manufacturer's directions. There should be defensive upkeep for these bits of equipment both internally and outwardly (vendor-provided services).




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