Refresher training of QC physical-and-chemical laboratory staff

Refresher training of QC physical-and-chemical laboratory staff

OBJECTIVE

  • To provide QC physical-and-chemical laboratory staff with the information about the necessity of refresher training for more effective work.

SCOPE 

  • This SOP is applicable to QC physical-and-chemical 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.

ATTACHMENTS 

  • Training & Qualification record        –      Attachment-I
  • Comprehensive Training record        –     Attachment-II
  • Certificate of Qualification                  –      Attachment-III

 

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 the information about seminars and conferences of quality control, certification and standardization which are held in Ukraine.
  • 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.

REFERENCES /

If any

ABREVIATIONS 

  • SOP: Standard Operating Procedure
  • QC: Quality Control Department
  • QA: Quality Assurance Department

DISTRIBUTUON LIST 

  • Quality Control Department
  • Quality Assurance Department

 HISTORY OF REVISION 

     Attachment-I

Training & Qualification record

Sr.NoTitle of SOP

    Attachment-II

Comprehensive Training record

Total No. of correct answers:

Total No. of incorrect answers :

Fulfill the requirements / Needs improvement

Checked by

Date

  Attachment-III

Certificate of Qualification 

 

For more Pharma Posts and Updates Click Here

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

Check Also

Procedure of the replacement procedure for the Purified Water Pump

To implement and procedure of the replacement procedure for the Purified Water Pump. This SOP …