SOP for Refresher Training of QC Laboratory Staff

OBJECTIVE

To provide QC laboratory staff with information about the necessity of refresher training for more effective work.

SCOPE

This SOP is applicable to QC laboratory staff.

RESPONSIBILITY

Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP.

ACCOUNTABILITY

QC Head and QA Head shall be accountable for the compliance of this SOP.

PROCEDURE

• Permanent training and refresher training of the staff is to be provided on-site (by qualified specialists) and off-side. For this purpose, one collects information about seminars and conferences on quality control, certification, and standardization.
• The theoretical and practical points are covered in the training plan for more effective work.
• The staff that has passed such training is prepared for appropriate work because the training improves his/her professional level and understanding of arising problems.
• Practical experience without appropriate training may cause faulty actions, and then miscalculations and non-compliance with normative requirements. Training of the laboratory staff is one of the most important factors for the implementation of the advanced GMP standards.
• The laboratory staff is to be well-orientated in the effective GMP requirements to follow its standards purposefully. Overall, a well-planned training program helps the staff to adapt to GMP requirements.
• Internal training is carried out by qualified laboratory specialists according to the staff training plan schedule.
• Internal and refresher Training of SOP, Traсking as per Attachment-I.
• Within the first 3 months of joining to the laboratory, staff must qualify for a theoretical exam for the analyst qualification evaluation in terms of knowledge of analytical methodology, as per Attachment II.
• After successful Qualification, the Person will get a Certificate of Qualification, as per Attachment-III.
• It is necessary to prepare the training plan in a way that every specialist of the laboratory passes alternately training courses of professional skills improvement in the field of instrumental analysis.

• To trace the staff work and training effectiveness, one is to complete the training records and from time to time conduct testing. This system favors the correctness of introduced mistakes or drawbacks.
• It is necessary to carry out the refresher course for the laboratory staff no seldom than once in 3 years.
• The QC Head is in charge of the refresher training of the laboratory staff.

ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control Department

QA: Quality Assurance Department

ATTACHMENTS

Training & Qualification record – Attachment-I

Comprehensive Training record – Attachment-II

Certificate of Qualification – Attachment-III

REVISION HISTORY

Nil

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