Un-Planned Deviation in Pharma

Un-Planned Deviation in Pharma

Investigation Report

Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators.

Type of deviation:  Un-Planned Deviation

Class of Deviation:  Minor

Date of investigation:  

Department:  Warehouse

Date of deviation Observed:  

Investigations start date:  

Investigation completion date:  

INVESTIGATION TEAM
S.No.NameDesignationDepartment
1.ManagerWarehouse
2.ManagerWarehouse
3.ManagerQuality Assurance
4.GM -QA/QCQuality Assurance

 Investigation / Finding of Deviation:

An investigation was initiated under unplanned deviation and the findings for the root cause of deviation is:-

  1. The cleaning operation performed by operator but document entry was not being done by the respective person in dispensing area only due to the “perceived” risk of soiling the documents.

Impact on Product Quality: No impact on product quality. 

Responsible personnel for deviation:

Corrective and/ or Preventive Action 

Proposed Corrective and Preventive Action : 

  1. Training to be conducted to all concerned operators and supervisors
  2. The verification of effectiveness and compliance of good documentation practice to be cover during internal audit in Warehouse quarter.

Corrective action: 

  1. Training has been imparted to all concerned operators and supervisors of the warehouse on good documentation practice and supporting

document attached with report. List is mentioned below:

Training attendance sheet

Training Material

Preventive Action:

  1. Re-training shall be extended to all personnel of other department on good documentation practice for more awareness on such type of deviation which do not occur in future (As per SOP No. ________________) by Date____________.
  2. The checklist of internal audit of warehouse has been revised and the statement is incorporated “Is the document entry done by the responsible person for that operation”.Revised checklist attached with this report.
  3. To ensure effectiveness and compliance with good documentation practice to eliminate the causes of such potential and undesirable situation in order to prevent re-occurrence in future.

Evaluation and Review of Implemented CAPA:

Verified the status of effectiveness and compliance of corrective and preventive action and found the activities fully implemented in warehouse and all the personnel understands and are aware of the criticality of activity that is performed.

 

Done ByChecked By Approved By
Name/ SignName/ SignName/ Sign

 

 

About Pharmaceutical Guidanace

Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

Check Also

ASSESSMENT OF QUALITY RISK

S0P OF ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

S0P OF ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION The quality objective of manufacturers is to …