Validation & Accredetation WING

Responsibilities of Validation Accredetation WING

Purpose:
  • The purpose of this Standard Operating procedure is to provide guidelines to the staff regarding the procedure to be followed for initial and continued training of pharmacist/Government Analyst and the staff of Quality Management System, working at Provincial Drug Testing Laboratories of Punjab
    • Scope:
  • This procedure is applicable to the Validation, Accreditation and Capacity Building (VAC) Wing of Provincial Quality Control Board.
    • Responsibility:
  • Computer operators: Computer Operator CO-04/CO-05
    To Dispatch the proposed training schedule to the concerned staff of DTL
    Pharmacist:
    To arrange the training session for the staff of the DTL on the directions of the Secretary PQCB.
  • Assist & coordinate with “Validation committees” constituted by PQCB for annual validations of instruments functioning in Drug Testing Laboratories, Punjab
  • Recommend measures for up-gradation of DTLs Punjab
  • Deal with all DTL issues i.e., extension in testing period, FNA cases, broken samples, insufficient samples quantity, missing Form 6 of errors in Forms, QMS, Testing Fee Structure, rationalization of number of samples, sample size, purchase & installment of equipment’s at DTLs and other issues
  • Maintain updated record of validations in his department
  • Direct the importers/manufacturers to provide Testing Methods and Reference Standards as & when required
  • Make schedule/arrangements for training programs to update Government Analysts and for improving their knowledge according to latest analytical method and technology
  • Take part in pipeline or new projects such as establishment of new DTLs &/or Appellate Laboratory, up-gradation of existing DTLs
  • Develop & maintain effective coordination, communication channel and exchange of knowledge, organizational learning & expertise with Technical Staff of Drugs testing laboratory
  • Work in coordination with the Director/Director Technical/Analysts of DTL to achieve above-mentioned objectives
  • Integrate and update information with Information Management Unit.
    • Responsibility:
    Assessment of the need of training of the staff of DTL:
    1. The team of the VAC Wing of PQCB will assess the need of in house, in the country and abroad training for the Government Analysts/QMS staff of the Provincial DTLs.
    2. The Vac Wing will discuss the possible areas for training with the Secretary PQCB and the Focal persons of the DTLs.
    3. After the selection of the particular area of the training and the specific speaker the VAC Wing will prepare the schedule of the training on the directions and recommendations of the Secretary PQCB.
      4. The training schedule contains following information:
      1. Title of the training
      2. Topic/Area of the training
      3. Name of the trainers
      4. Agenda of the training
      Training of pharmacist (DTL):
      1. For this purpose, the pharmacist (PH-14/ PH-15/ PH-16) VAC Wing will send the training schedule to the Director DTL of every DTL and through Diary and dispatch SOP No. 38.
      The training session is arranged according to agenda containing following parameters:
      1. Recitation of Holly Quran
      2. Introductory speech of the Chair
      3. Introduction to the speakers
      4. Schedule of Regular session of training
      5. Closing speech of the Secretary Chair
    4. The pharmacist (PH-14/ PH-15/ PH-16) VAC will ensure the marking of attendance of the participants of the training session on a specified format.
    5. After the training of the DTL staff trained staff will be directed to step down these trainings in house and will keep the record of this training.
    6. These step-down training will include pre and posttest to assess the capacity built after training.
    7. At the end of the training session the participants will be awarded with certificates of participation of the training on the prescribed format (Annexure-B).
    Afza Nazir

    Deputy Drugs Controller