What is Recall in Pharmaceutical Industry? Procedure involved in Product Recall

Product Recall means any action/procedure taken by the manufacturer, importer, marketer, supplier or registrant or enlistment holder of a product to remove it from the market or to retrieve from any person to whom it has been supplied because of the reason that the product;-

  • may be hazardous to health; or/and
  • may fail to conform to any claim made by its manufacturer, importer, registrant or enlistment holder relating to the quality, safety, efficacy or its usefulness; or/and
  • may not meet to the Quality Requirements;
Factors affecting Product Recall:
A pharmaceutical product may be recall from many reason as discussed above and other than discussed above. Due to complex distribution system and time taken process, 100% product recall from market is not possible. How much product will be received back depend at many factors like:
  • Time duration between manufacturing of batch and recall of product
  • Batch Size of Product recall
  • Nature of Product i.e. OTC, Prescription etc
  • Number of persons involves in Distribution Channel
  • Demand and Supply Ratio of Product (Consumption of Product)
  • Coverage Area of Product
  • Transportation Facilities, Time and Expanses during Recall
  • Expiry Date of Product
Types of Product Recall:
  • Voluntary
  • Requested by Authorities
Voluntary Product Recall:
If Product’s Manufacturer, importer, marketer, supplier or any other person involved in product distribution channel recall the product by itself  by finding product of inferior quality in re-checking, re-testing or any other way then it is Known as Voluntary Product Recall.

Requested by Concern Drug Authority:
If any Government Authority at concerned country responsible for pharmaceutical products standards and quality measures, finds product is not of standard quality (Failing of samples taken time by time) may request to concern person, institute or organisation to recall that product from market in Public interest.
In case concern person, institute or organisation don’t recall product at concern authority then concern authority may use its power to recall or force manufacturer or any other concern person to recall that product from market  
Procedure of Product Recall:
When a product is identified as of inferior quality or not of required standards, a product is recalled by its manufacturer, importer, marketer, supplier or any person involved into distribution channel. A product recall procedure involve following steps:
Step 1: In case of product recalled on request by Authority, Authority issue a letter confirming that product found of inferior quality or may not comply with standards as prescribed to the manufacturer, importer, marketer, supplier or any person involved into distribution channel. Involved person has to reply this letter at specific period of time. This letter may contains other required documents or details by drug authorities. Generally this letter asking the details as follow:
  • Confirmation of supply to whom sample taken
  • Source from where you obtained product (If you are not manufacturer)
  • Detailed Distribution report of that product along with invoice number, date and quantity
  • Issuing Recall letter to concern persons to whom you supply that product
  • Stock present at you
  • Attached list of test report issued by Authority Laboratory confirming found specification during testing
  • Any other detail if required 
In case of Voluntary Recall this step doesn’t involve. Internal test laboratory or any other laboratory confirms about product inferiority or lack of specific standards and starts recall procedure itself.

Step 2: Receiver has to reply the letter issued by concern drug authorities and Issue Recall Letter to all concern persons, firms, institutions or organisations to whom product has been supplied.
If you are a Pharmacy, then mention source of product as distributor or Stockist. Your customers to whom you supplied will be patients. If you are a Distributor or stockist then mention source of product as C&F or Manufacturer or Marketer or Importer. Distribution report will include all pharmacies chemist/retailers. If you are Carrying and Forwarding Agent (CNF) then mention source of product as Manufacturer or Marketer or Importer. Distribution list will include Distributors and Stockist detail. Marketing Companies or Importers will have to mention manufacturers from which to get manufactured or imported that product. Its Distribution report will include CNF or Stockist or Distributors. Manufacturer has to submit his own Certificate of Analysis reports and other testing quality procedure details carries during manufacturing of that product. And distribution report.

Step 3: A Recall letter has been issued by Manufacturer, importer, marketer or any other concern person. A manufacturer will issue Recall letter to CNF or Marketer or Importer. A CNF or Marketer or Importer will issue recall letter to Distributors or Stockists or CNF. A Distributor or Stockist will issue Recall Letter to Pharmacies/Retailers/Chemist. Further Pharmacy/Chemist may ask for return of product to patients but it’s practically not possible. Either patient may have consume it or it is difficult to locate patient easily. 

Step 4: Receiving of Recalled Stock and Destroyed by Manufacturer in presence of Concern Authorities.

hope above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Related Articles:

What is Quality Control? Basic Requirements for Quality Control

Quality Control means that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The basic requirements of quality control are that

  • Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes
  • Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by quality control
  • Test methods are validated
  • Records are made, manually or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated
  • The finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorization, are of the purity required, and are enclosed within their proper containers and correctly labelled
  • Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures
  • No batch of product is released for sale or supply prior to certification by an authorized person that it is in accordance with the requirements of the relevant authorizations
  • Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced
Related Articles:

What is Quality Assurance? Basic Principles of Quality Assurance

Quality assurance means the sum total of the organized arrangements made with the objective of ensuring that medicines and health products are of the quality required for their intended use. The system of quality assurance for the manufacture of medicines and health products should ensure that

  • Medicine and health products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice
  • Production and control operations are clearly specified and GMP adopted; 
  • Managerial responsibilities are clearly specified;
  • Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials
  • All necessary controls on intermediate products, and any other in-process controls and validations are carried out; 
  • Finished product is correctly processed and checked, according to the defined procedures; 
  • Alternative medicine and health products are not sold or supplied before an authorized person has certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicine and health products; 
  • Satisfactory arrangements exist to ensure, as far as possible, that the medicine and health products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life
  • There is a procedure for self inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system
Related Articles:

What is GMP and cGMP? Basic Principles of GMP and cGMP

GMP is a short form of Good Manufacturing Practice and cGMP is short form of Current Good Manufacturing Practice.

Good Manufacturing Practice is a way of manufacturing followed by manufacturing units to ensure quality and efficacy of a products. Good manufacturing practice is based at standards and guidelines recommended by licensing authorities. It involves production and testing practice that helps to ensure a quality product. It is based upon general principles that must be observed during manufacturing. It is not related to manufacturing procedure of any product. A company can fulfill gmp specifications and requirements while setting-up its quality program and manufacturing processes. Its company responsibility to determine the most effective and efficient quality process.

Basic Principles of GMP:

Basic principle of GMP is to ensure quality and efficacy of products. Many countries has implemented acts to mandatory follow o GMP procedures and have created their own GMP guidelines that are defined into acts and rules. Basic concepts of all of these guidelines remain same to ensure quality and efficacy of product and of safeguarding the health of the patient as well as producing good quality medicine.

Principals of Good Manufacturing Practice (GMP)” means that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification. GMP is concerned with both production and quality control. The basic principles of GMP are:

  • All manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required 
  • quality and complying with their specifications; 
  • critical steps of manufacturing processes and significant changes to the process are validated; 
  • Appropriately qualified and trained personnel; 
  • Adequate premises and space; 
  • Suitable equipment and services; 
  • Correct materials, containers and labels; 
  • Approved procedures and instructions; 
  • Suitable storage and transport; 
  • Instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided; 
  • Operators are trained to carry out procedures correctly; 
  • Records are made, manually or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated; 
  • Records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; 
  • The distribution (wholesaling) of the products minimizes any risk to their quality; 
  • A system is available to recall any batch of product, from sale or supply; 
  • Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent re-occurrence.
Related Articles:

Who is Production Supervisor? Definition, Job Responsibilities and Qualification

Production Supervisor:
Production Supervisor is a person who look after all daily activities of work and follow the instruction of manufacturing chemist. We can say, Production supervisor as semi-technical person to conduct, initiate and perform all manufacturing processes. Number of supervisors present into a unit depend at work load and production capacity of any manufacturing unit. A Production supervisor directly report to manufacturing chemist regarding daily routine.

How can we define Production Supervisor?
A Production Supervisor can be define as a person who is responsible for maintaining whole production at ground level and meet the defined standards for quality, efficacy and sustainability.

Job Responsibilities:

  • Responsible for maintaining and implementing Quality System
  • Take care of activities fall under his department
  • Direct supervisions to the professional, direct and indirect staff
  • Ensure manufacturing plans is achieved
  • Ensure quality, efficacy and sustainability of Product
  • Implement instruction received from Manufacturing Chemist
  • Coordinate with Quality control department for proper testing and quality
  • Execute production and resource schedule against production plan
  • Follow SOPs and ensure all activities should be perform as per SOPs.
  • Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
  • Review of completed manufacturing documentation per compliance standards and established timelines
  • Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
Qualification:
A Production Supervisor is considered as future Production Chemist. Qualification required for becoming Production supervisor is almost same as of production Chemist. But there is no experience required for starting job as production supervisor. Some companies require minimum of certain time period experience to start job as production supervisor.
Most of companies look minimum qualification of graduate in Pharmacy or Science for recruiting production supervisor.
Related Articles:

Machinery and Equipment for Pharmaceutical, Ayurvedic and Nutraceutical Manufacturing Plant

Essential Machinery and Equipment:All the machines are in SS-304 and contact part in SS-316

Liquid and Syrup Section:
  • High speed mixer for 500 liter/1000 liter tank
High Speed mixer with Stainless Steel Tank

High Speed Mixer
  • S. S. tank- 200 Liter/500 liter/1000 liter capacity with wheel and cover lid

Diagram
  • Colloidal Mill 
  • Liquid filling machine

  • P.P. cap sealing machine 

 

  • Liquid filtration unit
  • Tables
Capsule/ Tablet/Powder Section
  • Air compressor
 
  • Air conditioner
  • Blister packing machine
  • Alu-Alu Packing Machine:
  • Capsule filling machine:
Fully Automatic Capsule Filling Machine
Manual Capsule Filling Machine
Semi Automatic Capsule Filling Machine
  • Dehumidifier:
  • Tablet Punching Machine:
  • Coating Pan:
  • Sifter:
 
  • Mass Mixer:
  • Multi mill:
  • FBD- 30 kg// tray drier:
  • Double cone blender:
  • Powder Tin Filling and Sealing Machine:
  • Aluminium Tin Sealing Machine:
 
 
Miscellaneous:
  • Batch printing machine:
  • RO plant:
  • AHU (Air Handling Unit) and Air Lock System:
  • HVAC (Heating, ventilation and air conditioning System):
  • Lab equipment:
  • Balances

Who is Analytical Chemist? Definition, Job Responsibilities, Qualification etc.

Analytical Chemist:
A Pharmaceutical manufacturing unit requires two authorized person for smooth running. One is manufacturing chemist and Second is Analytical Chemist. Analytical Chemist is a person who are responsible for quality, efficacy and sustainability of the product.

Read Related: Who is Manufacturing Chemist? Definition, Qualification and Responsibilities

How can we define Analytical Chemist?

An Analytical Chemist is defined as an authorized person to conduct, perform and initiate all procedure related to testing of product and quality control. Analytical Chemist is also know
Quality Control Chemist or Manager. Analytical Chemist has responsibility to define and instruct his team members about testing process to ensure that the quality procedure should comply with required standards ,and quality, efficacy and sustainability of product could be maintained.  

Job responsibilities of Analytical Chemist:

  • Lead a team for carrying out activity related to testing and quality control procedure
  • Directing Quality team members regarding testing and quality cntrol processes.
  • Coordinating with manufacturing team for timely conducting tests during and after manufacturing process.
  • Technical Support on the quality control processes, software operation and data interpretation. 
  • Follow Master Formula Record and maintaining sustain quality of products.
  • To work in GMP environment by following quality control operations as per SOPs.
  • Comply to the regulatory requirements at each stage of activity
  • Maintaining Analytical records and 

Minimum qualification for Analytical chemist is as follow:
B.Pharmacy
Or
B.Sc. with minimum of three year experience in pharmaceutical product testing.

Hope this information is helpful to you…

Who is Manufacturing Chemist? Definition, Job Responsibilities, Qualification etc.

Manufacturing Chemist:
A Manufacturing chemist is a person who look after complete manufacturing process in a pharmaceutical manufacturing unit. Manufacturing chemist is top most technical staff who is directly responsible for all activities and processes during a batch manufacturing. He is responsible for sustain manufacturing process and quality product manufacturing. Manufacturing Chemist is a signatory officer. Without manufacturing chemist signature, a manufacturing batch can’t be dispatched to stock room.
How can we define Manufacturing Chemist?
A Manufacturing Chemist is defined as an authorized person to conduct, perform and initiate all procedure related to pharmaceutical products manufacturing. Manufacturing Chemist is also known as Production Chemist. Manufacturing Chemist has responsibility to define and instruct factory workers and supervisors about production process to ensure that the manufacturing procedure should comply with required standards ,and quality, efficacy and sustainability of product could be maintained.

Read Related: Who is Analytical Chemist? Definition, Job Responsibilities, Qualification etc

Job responsibilities of Manufacturing Chemist:
  • Lead a team for carrying out activity related to manufacturing procedure
  • Directing workers and Supervisors regarding manufacturing processes.
  • Coordinating with QA and QC team for quality production
  • Technical Support on the manufacturing processes, machine operation, record maintenance 
  • Follow Master Formula Record and maintaining sustain product manufacturing
  • To work in GMP environment by following procedure/production operations as per SOPs.
  • Comply to the regulatory requirements at each stage of activity
  • Maintaining Manufacturing Records and documentation
Query:
Sir can you please provide me the information regarding the qualification needed to open the pharma production unit as i went through your comments you have wrote registered pharmacist under state council. But sir I want to know whether bachelor degree is sufficient or one have to do masters for it.



Response:

For production unit, Manufacturing chemist requirement is necessary. For Pharma marketing company registered pharmacist is enough. A person can be registered pharmacist if he/she has Diploma, degree or higher Pharmacy education. But registered pharmacist qualification is not enough for pharma production unit. You have to be a manufacturing chemist approval.

Minimum qualification for manufacturing chemist is as follow:
B.Pharma with minimum of one and half year experience in pharmaceutical product manufacturing
Or
B.Sc. with minimum of three year experience in pharmaceutical product manufacturing.

Hope this information is helpful to you…

Kaise Ayurvedic Company Suru Kre?

Query:
Sir main BAMS doctor hu main 2-3 products reg kra k marketing krana chata hu. kis terha se reg krau aur kis terha se work start kru

Response:


Product registration do trah ka hota hai: Ek brand name registration or dusra product composition ka registration..

Humare article: Where to register ayurvedic products(click here) me aap complete detail pd skte hai.

Apne brand launch krne ke liye apko company registration (optional) krana pdega aur GST number lena padega. Uske bad aap kisi bhi ayurvedic manufacturer se contact krke apne brand name se product bnwa skte hai..

Umeed krte hai apko humara suggestion acha lga…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How and Where approach for Ayurvedic Manufacturing license?

Query:

I would like to share my query regarding , how and where approach for manufacturing licence?
Suppose, I have a seeds from a plant or tree to make herbal medicine (intake ) .what I need to do from there?
Whether I need to test any laboratory first or need to register the company first?
I need to know from scratch , that’s why requesting this query.
If they need test , then where to do the test (Kerala) and what will b the formalities . I need to start with small quantity and no need to plan for manufacturing unit now. Can invest in that once the bussiness is good . I need to do with third party manufacturing . Te product should be powdered and capsule form. Plz advice from where to start?

Response:

You have to approach State Ayurvedic and Indian System of Medicines Control Officer in Kerala or any concerned department of state for applying for manufacturing license. Most of states have appointed AYUSH Department for providing manufacturing license to Ayurvedic manufacturing license. Ayush department headquarter for most of states at Capital Region. Read in detail about Ayurvedic Manufacturing Company here

If you have seeds from a plant or tree, first you have to study about particular use and medicinal effects of that seed by studying at Ayurvedic Reference books like Ayurvedic Pharmacopoeia of India, Charaka Samhita, Pharmacognosy books or any other books. If that seeds has any medicinal effects then only these can be used for preparation of Ayurvedic Medicines. Testing laboratories are already situated inside manufacturing units. Read in detail about registration of an Ayurvedic Product before launching in india?

If you don’t have plan to launch own manufacturing unit, you can start by getting manufactured your products at third party or contarct manufacturing basis. Read about Ayurvedic Third party Manufacturing here

At third party manufacturing, either you can use preparations that are already used by Ayurvedic manufacturers or if you have special composition of preparartion, manufacturer will make arrangement for it approval…

Hope above informations are useful for you..

For any query and suggestion, mail at pharmafranchiseehelp@gmail.com