Procedure For Training Programme For Quality Control Personnel

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Procedure For Training Programme For Quality Control Personnel

1.0 Objective
Objective of this Standard Operating Procedure is to provide guidelines for training

programme for quality control personnel.
2.0 Scope
This training program is applicable for Quality control analyst in Quality Control Department.

It is written procedure will be follows for internal training. Internal training (on job training) will

be carried out by Asst. Manager-QC or trained personnel before or during the initial use of

a piece of equipment or new technique for analysis (Chemical, microbiological & Instrumental) at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 Asst. Manager-QC carry out the relevant training in QC department.
5.2 The Asst. Manager-QC will cover stability analysis also.
5.3 This training will cover Good Laboratory Practice also.
5.4 Other analyst may also carry out training on specific items of equipment or techniques

if they are trained in that field.
5.5 The types of documentation used in the QC and Stability study, will be shown, explained

and discussed with the analysts by the Asst. Manager –QC.
5.6 All SOP’s relevant to the work carried out in the QC department will be shown and fully explained

to the analyst before he or she carried out the procedure.
5.7 Before or initial using any instrument, the Analyst will receive SOP and training in the use

of the instrument and the documentation involved eg.
a) HPLC
b) UV Spectrophotometer
c) pH/Conducting meter
d) Balance
e) Chemical testing
f) Microbiological analysis
g) General Laboratory Equipment
h) Software Training for instrument operation etc.
5.8 On completion of training and receipt of a training record, the training record will be signed

and dated by the training co-ordinator.
5.9 The summary of all internal training carried out within the Quality Control.
5.10 Changes to procedures will be outlined to analysts as and when they occur. Retraining

will be carried out at the discretion of the Asst. Manager- QC or any Trainer. The analyst feels

that they require some form of retraining then they should notify the Asst. Manager-QC. The training

will then be programmed in to the fifteen days work schedule.
5.11 The summary checklist is provided to record a summary of training completed, therefore

becoming the official training record of the individual concerned. The checklist must be completed as required,
Detailing:
a) Trainee name
b) Subject
c) Point explained
d) Venue
e) Date & time training commenced
f) Date & time training completed
g) Trainee sign for completion of training
h) Trainer sign for completion of training
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History