Can I know about QMS

[Dilip_Singh]

Wht about QMS , is came under IPQA OR NOT

[Ankur (Ankur Choudhary)]

Quality management system (QMS) is a set of procedures and tools that help organizations achieve and maintain high levels of product quality. A QMS should be designed to meet the specific needs of the organization, and it should be tailored to the specific products and services that it produces. It should also include processes for measuring and tracking quality, as well as for correcting problems when they occur.
A good QMS will help an organization identify and fix problems with its products early on, before they cause serious damage. It will also help the organization track its progress over time, so that it can see how effective its Quality Management System is in achieving its goals.
Ideally, it is a part of quality assurance.

[Kamlesh (Kamlesh Patel)]

Quality Management System (QMS) is a important process to maintain Quality & Integrity of Product.

QMS is the key procedure to maintain quality, traceability and Integrity of product, facility, equipment etc.

QMS covered many things but the major topics / events I have covered in my article to share my experience and knowledge with you.

Main Six Topics / Events of QMS is,

Change Control
Deviation
CAPA
Market Complain / Customer Complain
OOS / OOC / OOT
Risk Management

1. Change Control: -

· Change Control procedure is for permanent change in process, equipment, document, facility,
product, data, authority etc. Which fall under cGMP documentation practice.

· Change Control is of two types,

Major
Minor
· Change Control for minor must be closed within 30 days and major change control must be closed within 90 days from initiation date.

· Some major change controls like facility modification, equipment Installation / qualification required time more than 90 days then change control extension form must be filed with proper justification.

· After Implementation of new change Impact Assessment must be done by QMS team.

· Change Control form (Format) is mainly covered information as below

Change Control No., Date of Initiation, Change Control Issued to & Issued By, Type of Change Control, Reference Document No. / Equipment No. (if any), Tentative date of closing,
Present Procedure
Proposed Procedure
Justification of Change
Acceptance Criteria
Enclosed Details
Internal department approval
Other concern department comment and approval
Regulatory department comment and approval (if any)
Quality Assurance Executive comments & approval
QA Manager / Head or Quality Head Approval
Impact Assessment after Implementation
Impact Assessment approval by QA
Closing with remarks

2. Deviation: -

· Any undesirable event that responds a departure from approved processes or procedures or
established standard or form what is required or acceptable.

· Two types of Deviation are as Planned or Unplanned.

· Deviations may be major or minor,

· Major: A Major deviation is an unplanned event that potentially affects a product’s quality, safety
or efficacy or its ability to meet specifications, or regulatory or documentation requirements, which
may or may not be affected on patient safety directly.

· Minor: A minor deviation is either planned or unplanned event that potentially has GMP impact
but does not affect product quality and / or physical state of the product, intermediate or
component or it’s labelling.

· Planned Deviation:

· Planned Deviation is also known as Temporary Change.

· Planned Deviation is only raised when QA team has its strong history trend & data, R&D or F&D
trail data and Strong Rational with proper Justification for particular deviation.

· Some best examples about Planned Deviation is

    Change in Batch Size
    Change in Equipment
    Change in RM (API) Vendor
   Change in Pack size etc.

· Important Note: - Investigation & Corrective Action-Preventive Action (CAPA) is not required, But
Risk Assessment must be performed in Planned Deviation.

· Planned Deviation form (Format) is covered mainly information as below

Planned Deviation no., Deviation initiation department, Form Issued & received by sign, Deviation related to…, reference no. (if any),
Current Practice, Current Practice reference document name & No.
Proposed Process
Justification & Rational
Acceptance Criteria
Past Deviation related to and it’s out come
Initiation department comment, action plan and approval
Other concern department comment and approval
Risk assessment report and assessed risk
Regulatory / client notification (if required)
Quality Assurance Executive comments & approval
QA Manager / Head or Quality Head Approval
Closing with remarks
· Unplanned Deviation: -

· Unplanned deviation occurs only during execution of planned process, process or activity.

· Unplanned deviation is never approved before the execution.

· Some best examples about Unplanned Deviation is,

Human Error
Deviation in Material qty changing, material qty addition
Calibration due but activity performed
Output (yield) beyond the range
Activity not carried as per Process, Procedure or Planner
Major Power Failure or Equipment failure during running process etc.
· Important Note: - Investigation, Corrective Action-Preventive Action (CAPA) and Risk Assessment
must be performed in Unplanned Deviation.

· Unplanned Deviation form (Format) is covered mainly information as below

Unplanned Deviation no., Deviation initiation department, Form Issued & received by sign, Deviation related to…, reference no. (if any),
Current Practice, Current Practice reference document name & No.
Unplanned process / activity / event occurred
Reason of Unplanned event
Justification by concerned department
Past Deviation related to and it’s out come
Investigation by QA
Route Cause
Corrective Action
Preventive Action
Initiation department comment and approval
Other concern department comment and approval
Risk assessment report and assessed risk
Regulatory / client notification (if required)
Quality Assurance Executive comments & approval
QA Manager / Head or Quality Head Approval
Closing with remarks

3. Corrective Action & Preventive Action (CAPA): -

· CAPA must be raised for the event which was investigated. Events like Unplanned Deviation,
Market Compliant, OOS, OOC, OOT, Non Compliance, Failure Investigation etc.

· Corrective Action shall be considered as your immediate action which is generated at the same
time of event.

· Preventive Action must be of that level of strong which gives complete assurance that such event
will not reoccurred in future.

· Training is never considered as a Preventive Action.

· Preventive Action must be documented on routine basis in any documents after its initiation.

· CAPA form (Format) is covered mainly information as below

CAPA no., CAPA initiation department, Form Issued & received by sign.
Corresponding Document Name & No.
Description of Non-Conformity
Corrective Action Taken
Concern Department & QA Approval on Corrective Action
Investigation of Non-conformity
Route Cause Analysis
Concerned Department Head Approval
Concerned Other Department comment and approval
Proposed Preventive Action
Target Completion Date for Preventive Action (if Any)
Revised Preventive Action (If Any)
Evaluation of Implemented Preventive Action (By QA)
Concerned Department Comment and sign
QA Executive Comment and Sign
QA Manager / Head Or Quality Head Comment and approval
Closing by QA
4) Market Complaint / Customer Complaint:-

· Complaints shall be divide into three category on the basis of criticality:

Critical Complaints
Major Complaints
Minor Complaints
· Critical Complaints:- The complaints related to defect in the product quality like purity, efficacy
and safety are known as Critical Complaints, which may lead to death of patients.

· For Example:

Cross Contamination of Product
Serious adverse reaction of product
Products failing in Sterility or Bacterial Endotoxin test (BET).
· Major Complaints:- The complaints, which lead to major problem in patient’s health because of
defect in product quality like purity, identity and reliability.

· For Example:

Loss of potency
Settlement of contents
Significant Discoloration
Wrong Printing of label claim or Expiry
· Minor Complaints:- The complaints related to defect in product quality like durability, filling defects
and packing defects, which leads to least problem with patient’s health.

· For Example:

Filling Defects
Packing Defects
Durability
· General flow for handling of market / customer complaints is as below

Receiving of Complaints
Allotment of respective complaint no.
Categories the nature of complaints
Review of Complaints
Investigation of Complaints
Evaluation of Investigation
CAPA (if any)
Closing of complaint with QA comments and approval
Send to Customer / client
Receive feedback from customer / client
· Closing Frequency for Complaints:-

Critical Complaints: Within 3 Days
Major Complaints: Within 7 Days
Minor Complaints: Within 15 to 30 Days

5) Out of Specification (OOS), Out of Calibration (OOC) & Out of Trend (OOT):-

· Out of Specification (OOS):-

· These events are mainly occurred in Quality Control (QC) and Micro lab.

· OOS events shall be noted for raw material, packing material analysis, In-process sample
analysis, finished product sample analysis, retain / control sample analysis or Stability Sample
Analysis.

· USFDA / EU / WHO / PIC’S guideline has given guideline on its evaluation as Investigation
Phase I & Phase II, while UK-MHRA guideline gives its investigation as Phase-I, Phase-II &
Phase –III.

· General Flow to handle OOS event is as below:

Requisition to be send to QA for OOS Form Issuance
QA will allot the respective no.
QA will Issue the Form with filled details like OOS No., Initiation Date, Form Issued by & received By, Brief description of event.
QC Senior / head along with QA start Investigation in Phase –I (Re- Measurement & Repeat Analysis of Sample)
If error identify in Phase-I then CAPA is generated and OOS shall be closed with remarks.
If error not identified in Phase-I then go for Phase-II & Phase-III (If applicable).
Investigation of Phase II & Phase III (if applicable)
Phase II Investigation includes Re-sampling, Different Analyst, Different System, Out Side Analysis etc as per SOP.
Then Evaluation of Investigation
Initiation of CAPA
Closing of complaint with remarks.
· Out of Calibration (OOC):- Chances of OOC occurrence is during Calibration, Usage of
Equipment / Instrument or during maintenance.

· If Out of Calibration (OOC) results observed, the analyst shall inform to Section In-charge and
section in-charge inform to Head-QC and QA Department.

· Then First step is affix label of out of calibration on Equipment/Instrument and OOC form shall be
issued from QA department.

· Jointly Investigation shall be started. The purpose of the investigation is to identify the root cause
for the OOC event. The Investigation shall be thorough, timely, unbiased, well documented and
scientifically sound.

· If out of calibration (OOC) results observed, the analyst shall not discard sample solution / stock
solution / Instrument setting until the evaluation of OOC results.

· Handling of Out of Calibration:-

· Issuance of OOC format from QA

· QA will allot no., make entry and take sign of issued by & received by sign,

· Concern person will write OOC details and Equipment / Instrument I’d.

· Investigation shall be started by Head QA & QA Concern.

· Preliminary Investigation Stage – I OOC (If the cause for failure is assignable)

· If Calibration found satisfactory then department head shall release the equipment / instrument
for use, after making necessary entries in the in format.

· If Calibration found not satisfactory then department head shall the procedure for the next stage
of investigation.

· Investigation Stage – II (To verify analytical practice / errors)

· Stage II – A (If Calibration found Satisfactory)

· Stage II – B ( If Calibration found not satisfactory)

· Investigation followed by Impact Analysis

· Trending and Evaluation of Out of Calibration (OOC)

· Department Head comments

· QA Comments & Closing

· Out of Trend (OOT):-

· Out of trend results shall be determined on the basis of the data of previous batches or previous
analytical data of previous batches or previous analysis. The result may be within the
specification but not the limit.

· OOT results may be occurred in QC lab or Micro lab. While routine operations.

· OOT SOP must cover the action limit & alert limit for out of Trend and it must be followed for each
operation.

· OOT may be occurred while Raw Material / Packing Material Analysis, In-process sample
analysis, Finished Product analysis, Stability Sample analysis or Retain / Control Sample
analysis.

· Once OOT is occurred then analyst first inform to section in-charge or head QC.

· Based on OOT cause section in-charge of head QC will plan reanalysis of sample or re-sampling
or system change etc.

· Out of Trend (OOT) will be handled by format its major content is as below,

· First QC people send requisition to QA for Issuance of Format for OOT and allot the respective
number, date of initiation, issued by and received by sign.

· QC person will fill the data as Product / Sample details, QC reference no., mfg. Date, exp. Date,
specification no., test name, test method no.

· Stage of testing.

· Standard test results and specification

· Details of abnormal observation noted during testing

· Laboratory Investigation with different check points

· Manufacturing Investigation (if Required)

· Route Cause Analysis

· Was similar OOT reported in last one year?

· Corrective Action

· Preventive Action

· Head – QC Comments & Approval

· QA department comment & Approval

· Closing remarks by QA Manager / Head / Quality Head & Closing

6. Risk Management: -

· Risk Management is a process that seeks to reduce the uncertainties of an action taken through
planning, organizing and controlling of both human and financial capital.

· Risk Management is very well described in ICH guideline chapter no. ICH Q9.

· Risk Management is process is as below,

Risk Identification
Risk Analysis
Risk Evaluation
Risk Reduction
Risk Acceptance
Risk Review

· With help of above six parameters Risk involved in all processes shall be managed.

· Risk Management is now a day’s basic requirements for organizations and infect Risk
Management is also part of ISO 9001:2015 quality standard.

· Every action has an equal reaction and when you take an attitude full of uncertainties in to a
project, process, activity you taking risk.

· The role of risk management process is to ensure that these project, process, activity questions
don’t cause future harm by maximizing all the good points and opportunities.

Hope you all understand my views on Quality Management System (QMS) a important process to maintain Quality & Integrity of Product.

Herewith above mentioned information is based on my knowledge and experience only.

Thanks,

Kamlesh

[Abiodun_Olupitan]

Thank you @Kamlesh for detailed and thorough explanation of what Quality management is all about. But, two things I’ll love to request or implore you to do;

1. The full letters of all Abbreviation used in your write up
2. A sample formats of the documents containing all you’ve said. You can perhaps, forwarded them to my mail for proper review. Thank you very much. My email: [email protected]