Annasaheb dange college of B pharmacy ashta

SUBJECT – INDUSTRIAL PHARMACY II

TOPIC NAME – OUT OF SPECIFICATION & CHANGE
CONTROL

Presented by –
Shriyesh sawant (104)
Pranali Shete (105) Under guidance of –
Saurabh Shete (106) Dr. Sandip Honmane
Abhay Shinde (107)
 Content -

 Introduction to OOS
 Procedure of OOS
 OOS investigations
 Scope of OOS
 Change control
 Procedure of change control
 Change control in pharmaceutical industries
 Introduction -

 Out of specification means the test result that falls outside the
specifications or acceptance criteria which has been specified in
official compendia monographs or finished product specifications in
registration dossiers.
 OOS is the comparison of one result versus a predetermined
specification criterion while OOT (out of trend) is the comparison of
many historical data versus time.
 OOS is observed in the analysis of :

 Stability study
 Finished product
 In process
 Raw materials
 Packaging materials
 USFDA guideline for industry investigating OOS testing results for
pharmaceutical production has two phases:
 PhaseI: Laboratory investigation: It includes an initial assessment of
accuracy of laboratory data.
 PhaseII: Full-scale OOS investigation: It consists of production
process review and or additional laboratory work.
 Procedure of OOS -

 Reporting to laboratory supervisor

 Recording and numbering of OOS
 Investigation by analyst
 Laboratory testing
 Approval by lab. Supervisor
 Testing by analyst
 Procedure of OOS-

 Preparation of Test report

 Evaluation of suspect results
 Investigation by technical management team
 Conclusion and report of data
 Evaluation by quality manager
 OOS investigations-

 Re-testing: The analysis of original sample at the time of Phase-I

laboratory investigation.
 Re-sampling: The original batch is sampled by QA second time
after QA head Authorization for re- analysis
 Re-analysis : The analysis of re-sampled material for the
verification of results, if manufacturing investigation does not have
root cause
 Scope of OOS -

 The purpose of OOS investigation is to determine the cause of OOS

result. The designated personnel classify the OOS as either
assignable cause or non assignable cause.
 The source of OOS result should be identified either as an aberration
of the measurement process (laboratory error) or an aberration of
manufacturing process
 Change control-

 Change refers to any modification to product, document, process,

equipment, instrument, system, facility etc.
 Change control is a formal system by which qualified representatives
of appropriate disciplines review proposed or actual changes they
might effect a validated status.
 Types of changes-
1) Major changes
2) Minor changes
 Scope of change control-

 Controlled documents of the QMS

 Any specification, in process control, CQA/CPP or any other criteria
with GMP impact
 Utilities, infrastructure or parts of the facility with GMP impact
 Equipmentwithin manufacturing, laboratories or other areas with
GMP impact.
 Procedure for change control-

1) Proposing a Change
2) Evaluating effect of change on product quality
3) Approval of a change
4) Implementing a change
5) Storage of completed change control
6) Trending change control metrics
7) Emergency change control
Procedure for change control -
 Change control in pharmaceutical
industries -

1) Production department: changes in location, equipment, critical

process control parameters etc.
2) Engineering department: change in equipment, facility and design
layout etc.
3) R&D department: change in specifications of raw materials/
finished products, quantity of raw materials, manufacturing steps,
shelf life, environmental conditions etc.
4) Materials department: Change in source of any raw materials or
primary packaging materials.
5) Quality control department: change in method of analysis,
sampling plans, stability protocols etc.
6) Quality assurance department: change in sampling plan/ quantity of
samples, validation protocols etc
7)IT department: change in hardware/ software
8) Cleaning department: change in cleaning steps, cleaning agents etc.