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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 compliance of this SOP.

PROCEDURE
  • Permanent training and refresher training of the staff are to be provided on-side (by qualified specialists) and off-side. For this purpose one collects information about seminars and conferences of 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 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, well-planned training program helps the staff to adapt to GMP requirements.
  • Internal training is carried out by the qualified laboratory specialists according to the staff training plan-schedule.
  • Internal and refresher Training of SOP, Traсking as per Attachment-I.
  • Within first 3 months joining to the laboratory, staff must qualified theoretical exam for the analyst qualification evaluation in terms of knowledge to analytical methodology, as per Attachment-II.
  • After successful Qualification, Person will get 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 course of professional skills improvement in the field of instrumental analysis.
  • For tracing of the staff work and training effectiveness one is to complete the training records and from time to time conduct testing. This system favours 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.
  • QC Head is in charge for 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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