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
Revision Number | Details For Change |
Reason for Revision |
00 | New SOP | NA |
Operating Procedure of Centrifuge
sop for preparation and storage of reagent solution
sop for Calibration and Maintenance of Laboratory Instruments and Equipment
Disposal of Residual Sample or Left Over Material
sop for for Laboratory Incident
standard operating procedure temperature monitoring
sop for operation of infrared moisture balance
sop for preparation of mobile phase
sop for Preparation and Issuance of Analysis protocol standard
sop of placebo and impurity stock solutions
sop for disposal of residual sample
sop for handling of pharmacopoeial changes
sop for procedure for operation of ultrasonic cleaner
difference between UPLC and HPLC
sop for for Emergency Eyewash and Shower
sop for operation and calibration of total organic carbon analyzers
sop for operation of cobb tester
sop for Operation and calibration of atomic absorption spectrophotometer
sop for Operation and calibration of gas liquid chromatograph
sop for operation of humidity oven
sop for operation and calibration of serological water bath
sop for monitoring of drain trap
sop for destruction of analytical samples after testing and control samples
sop for destruction of used chemicals
Sop for Operation of suction pump
sop for Operation and calibration uv cabinet
sop for Operation and calibration of bulk density apparatus
sop for operation and calibration of shore hardness tester
sop for operation of rub proofness tester
sop for monitoring of purified water
sop for Retesting of packaging materials
sop for Retesting and resampling of raw materials
sop for Control of issuance of record of analysis green sheets
sop for Control of computer passwords
sop for sampling of packaging materials PM
Operation and Calibration Procedure for pH Meter
Calibration of Melting Point Apparatus
Procedure For HPLC column washing procedure
Procedure For Retest Period of Raw Material
Procedure For Training Programme For Quality Control Personnel