SOP on Training of employees

 PROCEDURE:
Every employee of the organisation shall first undergo an Induction Training and
then to be trained on his / her area of operation prior to start the work. Induction
Training shall also include a visit and understanding of works done in
Departments other than their own. An Induction Training Record shall be
maintained for the new employee as per the Annexure, Orientation & Induction
training record. The training shall be imparted depending on the nature of job
and responsibilities and the cGMP training is mandatory for each employee.

 Training Plan
o The training needs shall be based on the criticality of the operation
performed by the employees working in different areas.
o Departmental HOD shall identify the need of training for different
levels. The training need identification shall be primarily based on
technical aspect related to the operational area.
o One week prior to execution of training, Quality Assurance
(responsible for Training) shall circulate a reminder to concerned
HOD, so that they can plan accordingly the activities of their
employees. Concerned department shall confirm the date of
training and shall inform to concern HOD about the date and time
of training session.
o All the respective department training record shall be maintained
by HR dept.
o induction Training should include cGMP / GLP / GEP / GDP
o also on Job training /Safety Training/Need base/Refreshing
training should be given to personnel
o Training should be given by level vise as pen there assigned
duties.
o Also Training of Regulatory guidelines has to given.
 Selection of Trainer
o Internal trainer from different departments shall be identified
based on his / her qualification, communication / presentation
skills, experience, knowledge and expertise or combination of
thereof in the different areas of operation.
o QA shall prepare list of internal trainers, which shall be approved
by Head – Quality Assurance The list shall be updated as and
when required.
o Prior to start of the training the participants shall fill their
attendance for all types of training .

 On the Job Training

 On the job training shall include the training in the concerned and cross
functional departments of the new employees and other as identified.
  On the job training shall be imparted to all the new joiner’s as well as to
existing employees by the concerned HOD or his / her designee related
to the area of operation. This training program shall include the training
related to the specific aspects of an individual’s role including use of
equipment, unit operations, safety norms to be followed and adherence
to cGMP.
 The mode of imparting training shall be through SOP’s, Cleaning
Procedures, Operating Instructions, Preventive Maintenance Procedures
and Practical Assessment wherever possible.

o Documentation

The documentation of different types of training shall be done by the

departments as mentioned below:

 Induction Training : HR / QA
 On the Job Training : Concerned Department
 Technical Training : Concerned Department
 For EU Training : EuDraLex VL- 4
 Representative from respective department shall coordinate with QA
dept. for conducting any training and maintaining the record of the same.
 Staff Training card of each employee shall be maintained by QA
department.

all personnel should have training records updated.

SOP on Handling of Incidents and Deviations

 PROCEDURE:

o
o Definition: Departure from an approved instruction or
established standard.
o Deviation shall be lodged when deviation from the written
procedure is observed / taken from following documents (but
not limited to):
o SOP
o BMR
o BPR
o STP
o SPEC.
o No deviation is permitted from Pharmacopoeia and other
Regulatory specifications. However additional steps for
betterment to pharmacopeial standard will not be treated as
deviation.
o In circumstances when it is not possible to follow the approved
procedure, or an error has occurred (Incident), in such cases
deviation must be raised in the prescribed deviation control
format by the initiator.
o The initiator must specify the deviation taken, the stage of
operation in the deviation control form and forward it to the
department Manager for review. If required additional sheet
shall be attached.
o The deviation form shall have the following information:
o Deviation Number, date, initiator department, allotted
by QA
o Nature of Deviation (Planned/Unplanned)
o Deviation Detail
o Material / Product / Procedure, Code, Batch Number, if
any.
o Preliminary investigation
o Root Cause
o Justification for deviation
o Corrective Action / Steps.
o Actions / Steps to Avoid Re-Occurrence
o Impact Analysis
o Comments of Other Affected Department
o Comments of Plant Manager
o Comments of customer / contract giver (If required)
o Recommendation and Final Approval by Manager
Quality Assurance
o Categorization of Deviation
o Compliance of Recommendations
o Deviation Control Numbering System for Planned & Unplanned
Deviation :
o The deviation number consists of eight alpha numeric
characters, where first character denotes type of
deviation i.e. ‘P’ (Planned) / ‘U’ (Unplanned) second
character is ‘-’ , next two characters denoting the year.
Fifth character is ‘-’ and next three characters are serial
number starting from ‘001’from the beginning of every
year.
o Example: The first planned deviation in the year 2018
shall be numbered as P-18-001 & first Unplanned
deviation in the year 2018 shall be numbered as U-18-
001
o Deviation may be planned or unplanned, if there is any deviation
is observed then it should be categorized as minor, major or
critical. The concerned department does the preliminary
investigation (if required).
o Root cause for deviation is to be identified and mentioned
which gives main reason or justification of deviation
occurrence.
o The department Manager must review proposed corrective
actions, along with the actions or steps taken to avoid the
reoccurrence of the same in future.
o Impact analysis shall be performed and documented in the
relevant section of the deviation control form by impacted
department Manager / other departments / QA.
Recommendation of the impact analysis shall be duly endorsed
by the Manager of the impacted departments.
o QA will forward the deviation to other affected department for
their comments (If required).
o If required comments of any department which is available
outside the plant, deviation should be forward to respective
department through scan copy / hard copy / any other
communication mode. Signed scan copy should be attached with
deviation (If required).
o R&D Manager must review the form for the impact in
coordination with the relevant department and give his
recommendations.
o Based on the review, Plant Manager must give his / her
comments to avoid such deviation in future.
o QA will forward the deviation to customer / contract giver for
their comments / review through scan copy / hard copy / any
other communication mode (If required). Signed scan copy
should be attached with deviation (If required).
o Manager QA/ Designee shall approve the deviation only if it is
justified and the corrective actions / steps for preventing
reoccurrence are satisfactory and the deviation does not have
any impact on the Strength, Identity, Safety, Purity and Quality
of the product and categorize as given below:
o Minor Deviation: Having no significant impact on product
quality and / or safety.
o Major – Having significant impact on product quality
and / or safety.
o Critical – Having Significant impact on product quality
and / or safety and likely to have a serious and a harmful
effect on the patient.
o In case of non-approval of the un-planned deviation by the
Manager QA, the batch in question shall not be processed
further and the recommendation of the Manager QA shall be
followed for further processing / rejection.
o In case the final disposition of the planned deviation is not done
(i.e. neither approved nor rejected) within seven days of
allotment of number from QA, the deviation shall be invalidated
and a fresh deviation is required to be filled if needed.
o The deviation shall be closed after implementation and
compliance of all the recommendations mentioned in the
impact analysis.
o The person / department initiating the deviation shall be
responsible for compliance of all the recommendations written
in the deviation control.
o Quality Assurance shall maintain the list of deviations occurred /
planned during the year.
o The deviation control should be closed normally within 30
working days from the approval of the deviation. In case this is
not done, the initiator department has to submit justification
with the approval of Manager QA.
o Product specific deviations should be closed before release of
batch. Copy of the deviation should be preserved with respective
batch record.
o Trend Analysis:
o Trend Analysis of deviations should be performed in start
of the next year by the QA department in the calendar
year
o Deviation should be preserved up to expiry + 1 year
(Product specific) or 05 years whichever is earlier.
o Product specific deviation shall be listed in APQR.