Month: September 2020

Procedure for Handling of Mock Recall

1.0Objective :
 To lay down the procedure for conducting Mock Recall.
2.0Scope :
 Scope of this document is to follow procedure for Mock Recall.
3.0Responsibility :
3.1Quality Assurance Department for conducting, monitoring and administration of Mock Recall procedure.
4.0Definition(s) of Mock Recall:
 Mock recalls are routine exercises conducted by manufacturers, processors, distributors and other various trading partners in the supply chain to assess their recall procedures and responsiveness. Mock recall has to confirm the efficient collation of batch history details and effectiveness of communication channels.
5.0Procedure :
5.1No contact shall be made with customers, contract clients & Regulatory Agencies, unless specifically authorized by Head – QA.
5.2Upon the direction of Head – QA or his designee “Mock Recall” shall be initiated to ensure that the established mechanisms that must be initiated during true  Product Recall are effective.
5.3A senior person from QA department shall be nominated to have management responsibility for the administration of the Mock Recall.
5.4Sufficient staff and appropriate priorities shall be assigned to allow the exercise to be conducted within one working day.
5.5For the purpose of this Mock Recall exercise, the Head – QA shall select a specific batch of distributed finished product that shall be considered the subject of Recall.
5.6Following points shall be referred for process of the Mock Recall.
5.6.1For a finished product, the primary objective is to be identified.
5.6.2The distribution history of that product batch or all batches of finished product in which the batch of active raw material used in the selected batch was used.
5.6.3The confirmed location of the batch production and packaging records associated with the above batches.
5.6.4The distribution history of batch or all batches of finished product in which that raw material lot was used.
5.6.5The amount and location of any remaining in-house stock of finished product batches / raw material.
  5.7The following additional information must be confirmed on each occasion.
5.7.1The current telephone and fax number of the Regulatory Agencies are available.
5.7.2Current telephone numbers are available for all distributors / customers identified in the Mock Recall.
5.8Only the procedures defined in SOP for Procedure for Product Recall must be used for this exercise.
5.9The formal protocol and report of the Mock Recall must be produced by the Quality Assurance person, and together with all records must be maintained for a minimum period of five years. The report must identify any procedural weakness highlighted by the exercise, and make specific recommendations for their resolution.
5.10It will be the responsibility of the Quality Assurance person to ensure that appropriate action is taken to implement those recommendations promptly to ensure that procedures are appropriate and up to date in the event of a true recall.
5.11Mock Recall exercise shall be carried out annually.
5.12An effort shall be made to close mock recall within time mentioned for the type of recall as per the “Procedure for Handling of Product Recall’’
 5.13Protocol & Report of Mock recall shall be numbered & same shall be entered in the numbering log.
6.0Distribution :
6.1This SOP (Controlled Copy) shall be distributed to Quality Assurance Department.
7.0Annex(es) :   
 Template for mock recall Protocol.
   Template for mock recall Report.
8.0 Reference(s) :
9.0             Abbreviations:
10.0SOP Revision History Record :
   Revision No. Details for Revision(s) with Change Control No. Effective Date (Sign. / Date)

Procedure for Trend Analysis

  • Objective :

To lay down a Procedure for Trend Analysis.

  •   Scope :

The scope of this document is to provide the Procedure for Trend Analysis of but not limited to Water analysis results, Environmental monitoring results, in Quality Control Department.

  •    Responsibility :
  •      Quality Control Personnel  :
  •       To prepare the trends of results.
  •      To review the trend analysis results.
  •       To determine the Alert and Action Limits.
  •       Head – Quality Control :

To review and monitor procedure for Trend Analysis.

  •      Head – Quality Assurance :

To review and approve Trends.

  •     Definition(s) :

Trend: A statistical term referring to the direction or rate of change of a variable(s).

  •    Procedure :
  •   Trend analysis shall be carried out as per requirement.
  •  Trend Analysis shall contains Month, Year, Sampling point Id, Area name, Room number, Sampling frequency, Standard Test procedure number, Specification limit, Alert limit & Action limit etc.
  •   Trend shall be prepared for individual tests and sampling point for water and individual room for environmental monitoring.
  •  Plot the graph of the trend results test wise and review the same against the data for correctness.
  •    The trend is applicable to parameters as given in table in point 5.6.
  • Table for Trending parameters and frequency
Sr. No.Type of StudyParametersFrequency
 1Potable waterpH , TVCMonthly Roll on Basis
 2Purified WaterpH, Conductivity, TOC, TVCMonthly Roll on Basis
 3Environmental Monitoring of Microbiology Testing Area by Settle plateTVCMonthly Roll on Basis
 4Environmental Monitoring of Microbiology Testing Area by Air samplingTVCMonthly Roll on Basis
 5Environmental Monitoring of Microbiology Testing Area by Surface MonitoringTVCMonthly Roll on Basis
 6Environmental Monitoring of Manufacturing Area ( Functioning Area ) by Settle plateTVCQuarterly Roll on Basis
 7Environmental Monitoring (Non  Functioning Area )  by Settle plateTVCYearly
 8Environmental Monitoring  of Manufacturing Area by Air samplingTVCYearly
 9Environmental Monitoring  of Manufacturing Area by Surface MonitoringTVCYearly
 10Microbiological monitoring of Compressed AirTVCYearly
  • The trend analysis can be performed for other tests as per requirements.
  • For the above studies, the trend results shall be made for daily acquired data during validation period or as and when required.
  • Prepare the trends as per the table in point 5.6.
  • Trend shall be prepared by user, reviewed by Head of the department or designee and approved by Quality Assurance.
  • All trends shall be reviewed for its correctness and provided with the remarks. Out trend/ out of specification or absence of data other then the frequency as mentioned in respective SOP shall be reported with reference of QMS documents (e.g. change control, deviation etc.).
  •  Distribution :

   This SOP (Controlled Copy) shall be distributed to Quality Control Department.

  • Annex(es) :
Annex No.Title
Annex – 1Template of Trend for Water
Annex – 2Template of Trend for Environmental Monitoring

      Abbreviations :

TOC : Total Organic Carbon

TVC  : Total Viable Count

QMS : Quality Management System

SOP : Standard Operating Procedure

 Reference(s) :


  • SOP Revision History Record :
Revision No.Details for Revision(s) with Change Control No.Effective Date  (Sign. / Date)

Control Sample Management in Pharmaceuticals

What is Control Sample:

An appropriately identified sample that is representative of each batch that shall be retained is known as control sample. These are also referred as retention or reserve sample.

Control samples shall be collected for Finished Product, Raw Material and Packing Materials.

Why Control Sample shall be collected:

As per regulatory and Customer requirements.

To perform Analysis in case of investigation or failure.

To perform investigation in case of market compliant.

For any additional testing if required 

Control sample shall be collected for fresh Raw & packing materials which are received at warehouse and for finished products it shall be collected for each batch, (commercial, Validation and optimization) market order and each type of pack style.

Sampling and storage of control samples (Raw materials, Packing materials & Finished Products) :

The quantity of reserve or control samples shall be collected at least twice the quantity necessary to perform complete analysis and same shall be entered in the control sample Register.

The control samples shall be stored in the same immediate container-closure system in which the drug product is to be marketed.

The control samples shall be stored under conditions as mentioned on the product label or store below 25°C.

For all drug products, the control samples shall be retained for not less than one year after the expiration date of the drug product.

Active Pharmaceutical Ingredients for which the manufacturer provides the date of expiry the control sample shall be stored for 1 Year after the expiry date. In case of excipients control sample shall be retained for 5 Years from the date of sampling.

Exhibit batch shall be stored up to the regulatory approval.

In case of withdrawal of control sample for investigation purpose the control sample issuance request form to be filled and same must be entered in the control sample record with appropriate reason.

Review of Finished product control samples:

 Control samples of all pack types of all batches and of products shall be examined visually at least once a year for evidence of product quality attributes & same shall be recorded.

Any evidence of reserve samples deterioration shall be investigated and necessary Corrective action and preventive action shall be taken.

Ten Tablets / Capsules shall be used for each visual inspection and shall be discarded.

 In case of Dry Syrup, One unit pack shall be used for each visual inspection and shall be discarded and in case of bottle pack control sample pack shall be re-sealed after visual inspection.

After withdrawal of sample for periodic review, balance quantity of batch shall updated in control sample record.

Destruction of Control Sample:

Every month Quality Assurance & Quality Control persons shall review the control register if any sample crossed the retention period.

Control samples of raw & packing materials and finished products shall be taken for destruction separately.

Quantity of control samples destroyed shall be entered in control sample register and same shall be checked by & verified by other persons.

For Destruction of Control Samples suspend them in a half filled container of water until the powder, tablets and the content of capsules are dispersed. Transfer the sample to be disposed into a plastic bucket containing 2 % NaOH Solution, make Slurry and the transfer into a polybag & send for destruction.

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