SOP For Quality Audit for Marketed Product

1. Purpose:  This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the quality audit of marketed product and to evaluation of counterfeit/falsified medicines in the market

2. Scope: This SOP is applicable to all marketed products with a view to evaluate their Performance under expected storage and operational conditions and to analyze the degree to which the product satisfies the customer’s expectations and Zero defect on quality including safety and reliability of the product and the evaluation of counterfeit/falsified medicines in the market

3. Reference and Attachments:

1. References:  
   1. In-house 
2. Attachments:
   1. Attachment 1 – Post marketing surveillance of marketed products form.
   2. Attachment 2 – Post marketing surveillance inward register.

4. Responsibility:

1. Head QA: 

1. To investigate incase of product failure.
2. To report Distribution in-case of failure.
3. To send requisition to distribution head for procurement of samples. 
4. To request distribution head to evaluate the availability of counterfeit/falsified     medicines in the market under the company’s name.
5. To record the report of post market surveillance of marketed products. 

5. Distribution:

1. Manager Quality (Master Copy)
2. Quality Assurance Department

6. Definition of Terms: 

1. PMS No. : Post marketing surveillance number
2. APR: Annual product review.

7. Procedure:

• 7.1.Quality assurance department:
  1. 7.1.1.Raise a requisition in a standard format for procurement of marketed product samples from various locations at regular intervals specifying the product quantity and location of sampling.
  2. 7.1.2.Send the requisition to the Head, distribution for further actions.
• 7.2.Distribution department:
  1. 7.2.1.Forward the requisition to the responsible persons, in-charge of the respective locations for withdrawal of the samples.
  2. 7.2.2.Forward the request to identify the issues of falsified/counterfeit medicines under the company’s name.
• 7.3.Location (storage site):
  1. 7.3.1.Withdraw randomly 3 strips from a box and check the strips for its total integrity. Report any damages or irregularities observed related to the       collected samples.
  2. and physical characteristics of the product during transportation.
  3. 7.3.3.Send the packed and properly labeled samples to the head, distribution department and corporate office.
• 7.4.Distribution Department:
  1. 7.4.1.On receipt of the samples, recheck the strips for any physical distortions or such other Observations.
  2. 7.4.2.Forward the samples along with a covering letter to quality assurance department for ‘further analysis and evaluation.
  3. 7.4.3.On receipt of request evaluate the any possibility of issues of falsified/counterfeit medicines under the company’s name.
• 7.5.Quality Assurance Department:
  1. 7.5.1.Enter the batch details of the sample received from the distribution                         department into a inward register along with other necessary details like date of receipt, place, quantity received. Any observations etc.
  2. 7.5.2.Prepare a test requisition for initiating the total quality analysis of the procured samples.
  3. 7.5.3.Send the requisition along with the concern samples to quality control department for its finished product analysis.
  4. 7.5.4.On receipt of the results from the quality control department, analyze, collect and interpret all information pertinent to the quality of the product and summarize the results in form of a report.
  5. 7.5.5.Maintain a copy of records in a file under the heading “Post marketing surveillance” for the specific products with head, quality assurance.
  6. 7.5.6.Head quality shall report instances of product failure or shortcomings, particularly for new products to responsible management in order to assure rapid corrective actions.
  7. 7.5.7.Include all results of post marketing surveillance as part of the annual periodic review report (APR) on quarterly basis for evaluating the continuous compliance of marketed products with laid down quality standards and statutory requirements.
• 7.6.Procedure for Post Marketing Surveillance Numbering system:
  1. 7.6.1.QA shall assign Post Marketing Surveillance Number as per following procedure.
  2. 7.6.2.Post Marketing Surveillance Number shall contain total 13 characters.
  3. 7.6.3.First six alphabets stands for Post Marketing Surveillance Number as “PMS No.”.
  4. 7.6.4.Next one character stands as “-”
  5. 7.6.5.Next three numerical shall be serial number, which starts from 001.
  6. 7.6.6.Next character stands as “/”.
  7. 7.6.7.Last two numeric stands for current year to be mentioned as 01, 02, 03 etc.

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