Month: January 2019

What is the Difference between Recall & Mock recall in Pharmaceutical

What is Recall of Product :

A product recall is a request from a manufacturer to return or removal of a  marketed product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller/ manufacturer at risk of legal action.

The manufacturer not only has  to pay  the cost of replacing & fixing of defective products but also it will down the image of Organization.

There are different types of recall i.e. Class I, Class II & Class III.

Class I :

A Recall situation in which there is a reasonable probability that the use of, or exposure to, a defective product is life threatening or could cause serious risk to health or death. Recall  and procedure to be initiated within 24 hrs.

Class II :

A Recall situation in which the use of, or exposure to, a defective product could cause illness or mistreatment but is not Class- I. Recall  and procedure to be initiated within 48 hrs.

Class III :

A Recall situation in which the use of, or exposure to, a defective product is not Class – I or Class – II and may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons.
To be recalled after hearing and answering show cause notice.

How to Conduct recall :

1.The manufacturer regulatory agencies shall get notification  regarding the recall

2. The product to be recalled  is in  the hands of consumers, through different medium like a press release or Electronic media .

3. The Product Recall form shall clearly mention the levels up to which (distribution / patient / depot) the recall effects shall be executed.

4. All the requirements of country specific Regulatory Authorities shall be completed jointly by manufacturer and agent as a distributor.

5. Recall status report shall be provided to the Regulatory Agency

6.  All the stocks returned from distribution should be sent by the market support services to the plant warehouse under intimation to the Regulatory Affairs department and location QA The location QA must reconcile the recalled stock .

7. The recalled goods and other inventory of the same batch or product in quarantine and shall be stored in a segregated area to avoid Mix-up with the other products.

8. The Recall will be closed (notifying the Regulatory Agency that Recall is considered      closed) and the contract companies or distributors shall be notified via mail when the regulatory agency acknowledges the termination of Recall.

9.  Efforts shall be made to close the recall procedure & A final status report and documentation of recalled product disposition should be provided to the Regulatory Agency.

10. The customer will get their refund depends upon the condition of the product.

11. The compensation may vary depends on the law of the particular country.

What is the meaning of Mock : 

Make a Duplicate or exact copy of something

What is Mock recall :

Mock recalls are routine exercises conducted by manufacturers, processors, distributors and other various trading partners in the supply chain to assess or verify their recall procedures and responsiveness and to train the recall team.

Mock recall has to confirm the efficient collation of batch history details and effectiveness of communication channels.

How to Conduct Mock Recall :

  1. Initiation of Mock Recall activity by the Manufacturer & select one batch which was distributed to the market .
  2. QA forward details of Product name with batch number to warehouse for the entire dispatch details
  3. Communication to Customer/Client for the execution of  Mock recall
  4. QA forward details to Marketing for the Confirmation of Dispatch details
  5. Communication to Qualified person/Customer for the execution of Mock recall
  6. QA forward details to Marketing  for the confirmation of dispatch details
  7. Marketing provide the details of the Distribution/Shipment
  8. Marketing Authorization Holder /Qualified Product Conduct Mock recall & Marketing Authorization Holder / Qualified person provides information to its warehouse/depot
  9. Reconciliation of Data at Qualified Person end & Qualified person shall mail receipt Data to QA Head.
  10. Reconciliation of Data from Manufacturer   end & if found Satisfactory Reconciliation then Closure of Mock recall.

The following information must be confirmed after Mock Recall :

1. The current telephone and fax number of the Regulatory Agencies are available.
2. Current telephone numbers are available for all distributors/customers identified in the Mock Recall.
3. Procedure for Product Recall must be used for this exercise.
4. The report must identify any procedural weakness highlighted by the exercise, and make specific recommendations for their resolution.
5. It will be the responsibility of the Manufacturer 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.

Conclusion :

A mock recall simulation is one of the best ways to test your recall plan and allows you to identify holes in your plan before it’s too late. It can also save your organization from wasting resources when a recall is necessary. Mock Recall exercise shall be carried out Yearly basis. Not only for Pharma but also for other industry like food, motor, beverage etc. Mock Recall is applicable.

Good Documentation Practices (GDP) in Pharmaceuticals

What is Document:

A piece of written, printed, or electronic matter that provides information or evidence or proof of any activity that serves as an official record.

Why Good Documents are Required in Pharmaceuticals :

1.If it isn’t documented, it didn’t happen & we document to provide written proof that something happened.

2.For regulatory requirements & business reasons- intent of making quality product or cost saving improvements.

3.To Compliance with the Food and Drug Administration’s (FDA), Good Laboratory  Practices, regulations (21 CFR Part 58), as well as GMP (Good Manufacturing practices) regulations for drugs and   medical devices (21 CFR Parts 211 and 820) requires the use of Good Documentation Practices.

4.Good Documentation Practices (GDP) apply to everyone who documents activities related to cGMP (Current Good Manufacturing practices).

5.A key to Good Documentation Practices is to consider these questions each time you record your raw data:

  a. is it true?                                c.    Is it timely?

 b.  is it accurate?                        d.    Is it legible?

What is Good Manufacturing practices (GMP) :

It is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

What is Current Good Manufacturing practices (cGMP) :

The letter “c” stands for “current,” reminding manufacturers that they must employ technologies and systems that are up-to-date in order to comply with the regulation.

What is Standard Operating Procedure (SOP) :

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization.

Instructions to be followed for Good Documentation Practices (GDP) in Pharmaceuticals :

  1. Write what you do, do what is written
  2. Document shall be made clearly, readable, legible, accurate, prompt & consistent with water proof, nonfadable writing instrument, so that information cannot be erased or changed & easy to understand.
  3. All documents / data should be written, signed and dated with permanent ink pen.
  4. Date shall be written on the documents in the pattern of DD/MM/YY or DD/MM/YYYY & For the time, use 24 hours clock. No AM or PM shall be used. Time format shall be as HH:MM and wherever applicable time format shall be as HH:MM:SS.
  5. Any mistake while recording the data during operation should not be corrected with “Whitener”, “Eraser” and “Overwriting” on the same.
  6. In such case the wrong word is to be cancelled with horizontal cut line or striking-off the single line (i.e. Wrong) and rewrite the correct word with ink pen.
  7. After cancellation and necessary correction the concerned person should put the valuable reason (if applicable) with signature and date. The reasons such as entry error, calculation error, printing error, transcription error, typographical error etc. can be used as applicable and as suitable. If sufficient space is not available for writing the reason, correction shall be numbered sequentially from 01 and the same shall be described at bottom of respective page by concerned person with signature and date.
  8. Document entries should be done only by authorized person for that operation & don’t use pencil for writing the documents / data.
  9. Where the Ink Jet / Ribbon / any other Printer are used for presenting the data (Computer generated Report), the printing must be dark, clear, readable All computer generated reports must be reviewed, signed and dated.
  10. Preferably, documents shall be prepared on “A4” size paper i.e. for Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR), Analytical Work Sheet, Qualification Documents, Validation Protocols, or other cGMP Documentation.
  11. Photocopy of any document without stamp shall be considered as “Uncontrolled Document”.
  12. Use of thermal paper for printing / documentation is to be avoided. Wherever required for printout, clear photocopy duly signed and dated shall be attached.
  13. “Ditto Marks” (—-”——-) shall not be used for documentation.
  14. “Bracketing” shall not be done for documentation.
  15. In case issued document requires entry of additional data, information / addition of text matter which is not provided in the document, same shall be written legibly and shall be initiated by the person making the entry.
  16. Whenever more than one option is available, encircle / tick the option which one is applicable. e.g. Batch Manufacturing Record, Analytical Worksheet etc.

  Do’s :  

  1. The Standard Operating Procedures (SOPs) shall be prepared to make the work simple, understanding the subject and for systematic working. 
  2. The “DISPLAY COPY” of the Standard Operating Procedures should be available in the designated area / near the Equipment and Instrument.
  3. In case of any Change / Clarity / Amendment related to procedure / practical applicability as mentioned in Standard Operating Procedure, consult the concerned Supervisor / Department Head.
  4. Always follow the procedure mentioned in the Standard Operating Procedure for effective and good documentation.
  5. If required, a remark shall be entered for any incorrect entries by the concerned Operator / Supervisor.
  6. Always maintain online documentation First perform the activity and then immediately document the same to achieve error less document.
  7. Always use Approved / Current Formats / Data Sheets for recording data.

Don’ts :

1. Don’t use any other method or procedure in place of the written approved procedure (Discuss in case of a better way of executing the procedure with the concerned Supervisor / Department – Head and implement only on revision of the SOP).

2. Don’t by pass any step of the Standard Operating Procedure to make work easy.

3. Don’t document the activity before or without performing the activity.

4. Don’t keep any column blank, all cell provided for the recording of data shall be filled. When a particular point is not applicable it should be written as “NA” in the space provided for the data entry and “Nil” in case of quantitative data entry not required, use of dash (–) is prohibited. If there is any blank space after recording the data on a paper, it has to be cancelled by striking off line ( \ ) from left top corner to right bottom corner with “NA” followed by sign & date.

5. Don’t write any details in a chit of paper or palm.

6. Don’t write any record (cGMP Document) in vernacular language.

7.Don’t handle documents in an unsystematic way.

Data Integrity Principles ALCOA & ALCOA PLUS in Pharma

Data Integrity Principles :

Data Integrity as per United states Foods & Drugs Administration (USFDA) :

Data integrity refers to the completeness, consistency, and accuracy of data. Complete,consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA).

Data Integrity as per Medicines and Healthcare products Regulatory Agency (MHRA) :

Data integrity is defined as ”the extent to which all data are complete, consistent and accurate throughout the data lifecycle”.

What is Meaning by Data Life Cycle :

All phases in the life of the data (including raw data) from initial generation and recording through processing, use, data retention, archive/retrieval and destruction.

Basic Requirement of Data Integrity :

  1. Every employee shall be responsible for ensuring data integrity and GXP practices in area of operation. GXP meaning Good “X” Practices used as Manufacturing/Documentation/Laboratory/Distribution.
  2. Every employee shall ensure that generated data is complete,
    consistent and accurate in all its form i.e manual (paper) and electronic data.
  3. Data governance shall clarify data ownership and accountability throughout the lifecycle where design, operation and monitoring of processes/system shall be considered in order to comply with the principles of data integrity.
  4. Data governance shall include staff training in the importance of data integrity principles & the creation of a working environment that encourages an open reporting culture for errors, omissions & undesirable results

Data Governance : 

The sum total of  arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the life cycle.

Data Integrity Principles ALCOA & ALCOA PLUS (CCEA)