Maintaining product quality and ensuring patient safety are the most important tasks in pharmaceutical industry. Unplanned events are one of the key elements in achieving product quality. Deviations are events that depart from standard operating procedures, batch records and regulatory requirements.
If you are working in manufacturing, quality assurance or compliance, understanding deviation management is important. This article explains deviations in detail, why they matter, and how to manage them according to good manufacturing practices.
Example: Using raw material from an alternative supplier due to supply chain disruption.
Example: The production operator forgets to record a production parameter in the batch manufacturing record.
Example: A critical process parameter is found out of specification (OOS).
Example: Missing a non-critical log book entry.
If you are working in manufacturing, quality assurance or compliance, understanding deviation management is important. This article explains deviations in detail, why they matter, and how to manage them according to good manufacturing practices.
What is a Deviation in Pharmaceuticals?
Deviation is any departure from approved procedures, processes or specifications that may impact product quality, safety or efficacy. Deviations may occur during the manufacturing process, packaging, labeling, testing, storage or any part of the product lifecycle. The following are some examples of deviations.- Failure to follow an SOP
- Equipment malfunction during batch processing
- Temperature excursion during material storage
- Incorrect entry in batch production record
- Missing line clearance documentation
Types of Deviations
In pharmaceutical companies, deviations are categorized into the following types.1. Planned Deviation
A planned deviation is pre-approved and documented before it is executed. These are temporary changes to the procedures or processes to fulfill the temporary process requirements.Example: Using raw material from an alternative supplier due to supply chain disruption.
2. Unplanned Deviation
An unapproved deviation occurs unexpectedly and it is not approved in advance. These types of deviations require an immediate investigation because they can impact the product quality.Example: The production operator forgets to record a production parameter in the batch manufacturing record.
3. Major Deviation
A major deviation affects product quality, safety or regulatory compliance.Example: A critical process parameter is found out of specification (OOS).
4. Minor Deviation
In minor deviations, the product quality, safety, or effectiveness is not impacted, no documentation or critical errors are involved and it does not affect regulatory compliance.Example: Missing a non-critical log book entry.
Why is Deviation Management Important?
Deviation Management is important because it is critical for:- Maintaining product quality and consistency
- Ensuring compliance with FDA, EMA, WHO and other regulatory bodies
- Achieve continuous improvement
- Preventing recurrence of issues
- Avoiding the regulatory penalties and warning letters
Key Steps in Deviation Management
Deviation handling follows a structured approach and includes following steps.Step 1. Deviation Reporting
Training must be given to all employees to report a deviation immediately. A deviation report should include description of event, date and time, equipment involved, persons involved and impact on the batch or process. Many companies use an electronic quality management system (eQMS) to log and track deviations and change controls.Step 2. Impact Assessment
A cross functional team including QA, manufacturing, quality control and engineering must evaluate the deviation’s impact on product quality, product integrity, regulatory compliance, ongoing and failed batches and classify the impact as no impact, potential impact and confirmed impact.Step 3. Root Cause Analysis (RCA)
A proper investigation is essential to determine the actual cause of deviation. Root cause analysis methods include 5 whys analysis, fishbone diagram, fault tree analysis (FTA) and Pareto chart analysis. Division may occur due to many regions, some root causes include human error, equipment failure, material issues, documentation errors, environmental conditions or improper training.Step 4. Implementation of CAPA
On the basis of root cause analysis, corrective and preventive actions must be implemented to correct the current issue and prevent its reoccurrence in future. Corrective and preventive actions include revision of SOPs, retraining staff, repairing or upgrading equipment and implementation of automation or error proofing.Step 5. Effectiveness Check
After proper implementation of corrective and preventive actions, a follow up should be taken to confirm the effectiveness of the addressed deviation. This follow-up may include self-inspection, trend analysis and retesting or revalidation of the process. An adequate further action must be taken if the CAPA is found ineffective.Step 6. Documentation
Documentation on every step is important in pharmaceutical deviations. Each deviation report should include deviation reference number, detailed event description, impact analysis, root cause analysis summary, CAPA Plan, approval and closure date. These records must be audit ready and retained as per good documentation practices for GMP.Related: Difference between Incidence and Deviation
2. The location head Technical director shall comment on the deviation.
3. Comments by Regulatory & product development deptt. Are made whether validation. Stability study for change control required or not.
4. Decision regarding approval / non-approval of the deviation shall be taken by Q.A. Manager in case of the loan license party or by technical director in case of Promed product.
5. Closer remark shall be made mentioning B.No. & date of completion.
EMA (Europe): EU GMP guidelines Chapter 1: Pharmaceutical Quality System and Chapter 8: Complaints and Product Recall says proper deviation reporting, investigation and continuous improvement.
WHO & PIC/S: Global regulatory bodies like WHO and PIC/S align with ICH Q10 principles and demand effective deviation management as a part of quality system.
1. Lack of training – Employees don’t have training of standard operating procedures they are following.
2. Inadequate SOPs – Unclear or missing instructions in standard operating procedures.
3. Poor maintenance – Poor maintenance causes equipment malfunctions and issues in manufacturing process.
4. Documentation gaps – Documentation of manufacturing process in BMRs remains missing or incomplete.
5. Environmental fluctuations – Environmental conditions like temperature and humidity remain outside acceptable ranges.
6. Miscommunication – Sometimes, miscommunication happens during shift handovers.
A quality focused culture that usage structured root cause analysis (RCA) tools and implementing effective CAPAs, a pharmaceutical company can transform deviations into opportunities for continuous improvement of quality management system (QMS).
Major Deviations – Deviations those may have potential impact on product quality or regulatory compliance.
Critical Deviation – Deviations those have a definite impact on product safety, efficacy, or GMP compliance.
Procedure for Raising Deviation Report
1. Request for deviation shall be raised by manager of respective department. In the approved format (Annexure 1) with justification for deviations.2. The location head Technical director shall comment on the deviation.
3. Comments by Regulatory & product development deptt. Are made whether validation. Stability study for change control required or not.
4. Decision regarding approval / non-approval of the deviation shall be taken by Q.A. Manager in case of the loan license party or by technical director in case of Promed product.
5. Closer remark shall be made mentioning B.No. & date of completion.
DEVIATION REPORT FORMAT
1. Deviation Report Number ___________________
2. Name of Munufacurer ______________________
3. Product Details
Product
|
Batch No.
|
Market
|
Pack Size.
|
Mfg.Date
|
Exp.Date
|
Types of Deviation:-
Planned Unplanned
Description of Deviation_______________________________________________________________
Stage_____________________________________________________________________________
Observed by:- _____________________________________________________________________
4. Justification:- ___________________________________________________________________
___________________ __________________ __________________
Mfg. Location Initiated by (Name) Signature & Date
5. Comments by Location Head: _______________________________________________________
___________________ _______________________
Location Head (Name) Signature & Date
6. Decision by Q.A.M
Approved Not Approved
Remarks:-________________________________________________________________________
_________________ _______________________
Name Signature & Date
7. Closer Remarks:-
Date of Implementation:_____________________
Involved Batch No.: ______________________
Remark: __________________________________________________________________________
_____________________ _______________________
Location Head QA Signature & Date
Regulatory Expectations
FDA (United States): The FDA 21 CFR Part 211.100 and 211.192 require Proper documentation and investigation of any unexpected event. Failure to handle the deviation properly can result form 483 observations and warning letters.EMA (Europe): EU GMP guidelines Chapter 1: Pharmaceutical Quality System and Chapter 8: Complaints and Product Recall says proper deviation reporting, investigation and continuous improvement.
WHO & PIC/S: Global regulatory bodies like WHO and PIC/S align with ICH Q10 principles and demand effective deviation management as a part of quality system.
Common Deviation Causes
Understanding the frequent causes of deviation can help to reduce deviation rates in pharmaceuticals. Following are some common regions that trigger deviations and pharmaceutical industry.1. Lack of training – Employees don’t have training of standard operating procedures they are following.
2. Inadequate SOPs – Unclear or missing instructions in standard operating procedures.
3. Poor maintenance – Poor maintenance causes equipment malfunctions and issues in manufacturing process.
4. Documentation gaps – Documentation of manufacturing process in BMRs remains missing or incomplete.
5. Environmental fluctuations – Environmental conditions like temperature and humidity remain outside acceptable ranges.
6. Miscommunication – Sometimes, miscommunication happens during shift handovers.
Best Practices for Deviation Control
To strengthen your deviation management process, you can follow these practices.- Implement real time reporting using digital tools or mobile apps
- Encourage no blame culture when deviations are reported without any fear
- Always perform trend analysis to identify recurring patterns
- Regularly train staff on deviation handling and their investigation techniques
- Standardize root cause analysis methods to ensure consistency
- Involve cross functional teams from all departments in every investigation
- Audit the deviation system periodically to identify gaps
Role of Quality Assurance in Deviation Handling
Quality assurance is the security guard of deviation management and is responsible for- Reviewing and approving deviation reports
- Ensuring timely closure of deviations
- Approving corrective and preventive actions
- Communicating with regulatory bodies when necessary
- Trending data to identify systematic issues.
A quality focused culture that usage structured root cause analysis (RCA) tools and implementing effective CAPAs, a pharmaceutical company can transform deviations into opportunities for continuous improvement of quality management system (QMS).
Frequently Asked Questions (FAQs) on Deviation Control
Q1. What are the main types of deviations?
Answer: Minor Deviations – Deviations those don’t have any direct impact on product quality, safety, or efficacy.Major Deviations – Deviations those may have potential impact on product quality or regulatory compliance.
Critical Deviation – Deviations those have a definite impact on product safety, efficacy, or GMP compliance.
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