Friday, December 7, 2012

Product Development Department in Pharmaceutical Industry


Product Development Department

Many companies market have same drug products, but not all are identical in context to physical parameters which in turn affect the biological aspects like absorption and distribution of a drug. Quality of a drug product depends on quality of formulation. Product Development Department successfully does it all.

Functions of Product Development Department
Æ  Launching of a New product
Æ  Reformulation
Æ  Reprocess
Æ  Trouble shooting
Æ  Preparation of B.M.R. for a new product.
Æ  Development of existing product.

New Product launching:
For launching a new product, product development department follow the following steps-


The pre formulation study consists of:
1.      Raw material specification
2.      Product specification
3.      Pharmacological action
4.      Toxicology
5.      Formulation
6.      Manufacturing
7.      Market product study: if the product is new for our country or the product is exsting in the local market.
8.      Packaging.
9.      Stability testing
10.  Analysis

Development of existing product:
Existing products demand research in order to: 
Ä  Increasing the quality of the product.
Ä  Prevention of any type of problem existing in the product.
Ä  To save time and cost.
Increasing the patient acceptance
Reprocessing:
Reprocessing is done for finished product if it fails quality control test due to shortage of any excipient or active ingredient. In such case the finished product is crushed and shortage amount is mixed is processed and a new BMR is prepared.
Trouble shooting:
Product Development also solves various in process problem during a batch production.
Instruments available at PD core area
Granulation Room

Ä  PMS Fluid Bed Processor
Ä  GHL High Speed Mixer Granulator (SMG)
Ä  Drum Blender
Ä  Electrical Heater
Ä  PMS Granulator
Ä  Electronic Top Loading Balance
Ä  Super Mixer Grinder
Ä  Vibro-Sifter
Ä  Hot Melt Granulator

Compression Room
Ä  Cadmach(CM3B)
Ä  Hardness Tester
Ä  Hand Filling Capsule Machine
Ä  Mettler Tolledo E. Balance
Ä  Vacuum Cleaner


Coating Room
Ä  Magnetic Stirrer
Ä  BOSCH Stirrer
Ä  Thai Coater
Ä  Coating Machine (Kevin)
Wurster Room
Æ  Wurster Coater

Core Area
Ä  Hot Air Oven
Ä  Hot Air Sterilizer
Ä  High Shear Laboratory Mixer (Silverson)
Ä  Adventurer Electronic Balance
LCO
Æ  Laminar Air Flow Hood
Washing and Sterilizing Area
Æ  Water Distillation Machine
Sterile Filling Area
Ä  Laboratory Autoclave
Ä  Laminar Flow Unit
Ä  Check Station

Steps of Product Development Personnel To Launching A New Product:
Phase: 01 - Information
[  NFD & Pre-NFD information
Ä  Fill-up a pre-NFD form
Ä  Approval by engineering, production & QC department
Ä  Approval of NFD
Ä  Send approval NFD to PMD & QC
Ä  Mention if there are any other special criteria
Phase: 02 – Research
[  Literature Search & Project Planning
Ä  Book Research
Ä  Internet search
Ä  Innovators Web search
Ä  PD Project Planning
Ä  Product Development Requisition
[  Material Sourcing
Ä  Sourcing of active Raw material
Ä  Potential Supplier List
Ä  Sample for analytical development
Ä  Reference sample collection.
Ä  API analytical report.
Ä  Excipients testing (Special Items only) report
[  Active Purchasing/ Collection for PD
Ä  Sourcing of active Raw material
Ä  Potential Supplier List
Ä  Support of OSD 
[  Active Testing & Method validation
Ä  Method Validation for Active
Ä  Method validation for Finished Products




[  Pre-formulation studies
Ä   Major Pre-formulation parameters of API
Ä   Brand Products Formulation/Excipient Selection
Ä   Binary Incompatibility study report
Ä   Critical Pre-formulation research
[  Innovator’s/Brand Product Purchasing
Ä   Physician Desk Reference
Ä   Out sourcing 
[  Innovator’s/Brand leaders Product Testing
Ä  Physico-chemical Testing
Ä  Primary Packaging component report
[  Primary Packaging Material selection
Ä   Incompatibility analysis with primary packaging.
Ä  Analysis of Product Critical Factors
Ä  Analysis of Process critical factors
Ä  Prototype formulation
Ä  Manufacturing flow chart
[  Product Brief and Specifications
Ä  Drug information Search
Ä  Brand and pilot batch Analysis Report
Ä  Prototype formulation
Ä  BMR of new product

Phase: 03 – Formulation
[  Lab batch & Stability Batch Preparation
Ä  Preparation of Laboratory Batch
Ä  Packaging of Laboratory Batch.
[  Analytical Evaluation of Finished Products
Ä  Chemical Analysis
Ä  Physical Analysis
Phase: 04 – Stability Study
[  Stability Study
Ä  Stability study report-1 Month
Ä  Stability study report-3 Month
Ä  Stability study report-6 Month
Review and Specification Approval
 Phase: 05 – Scalae-Up and Production
[  1st Scale-up Batch Production
Ä  Analysis of 1st Scale-up Batch
[  2nd Scale-up Batch Production
Ä  Analysis of 2nd Scale-up Batch
[  3rd Scale-up Batch Production
Ä   Analysis of 3rd Scale-up Batch

[  Process Validation & Reporting
Ä  Process Qualification
Ä  Production Facilities
Ä  Production & Packaging environment
Ä  Batch Documentation

22 comments:

  1. Well..The blog post is truly up to the mark.. i must say the information you have shared with us is perfectly great...
    ATSTAT 10 (SS) 10X10
    Indian Pharma Industry
    Pharmaceutical Company India

    ReplyDelete
  2. In that industries when we get the project or tender For Maintenance purpose. First the safety dept analysis the value of the work. If incase the maintenance for mep. They hired the product in some contractor for example Scissor lift, Boom Lift, Movable Aluminium Scaffolding

    ReplyDelete
  3. Thanks for the helpful information.
    EXCELLENT WORK ALSO.

    ReplyDelete
  4. Thanks for writing such an informative blog.
    If you are looking for pharmaceuticals formulation development
    then do consider Gvkbio.

    ReplyDelete
  5. Package-level integrated products require assembly of multiple bare die into the package . But most MEMS die can only be fully tested after they have been packaged. This is due to the fact that it is easier for die to be handled, exposed to test stimuli (pressure, acceleration, chemistry, and so on), and electrically read out/driven after the die have been packaged. definitions of thought leadership

    ReplyDelete
  6. Bare MEMS chips are delicate due to their microscale features. They are vulnerable to many hazards in the surrounding environment, including humidity, water, electrostatic discharge, rough handling, dust particles, and much more. strategic thought leadership

    ReplyDelete
  7. The first BEOL step is wafer sort, also called wafer probing. The wafer is held by a vacuum chuck, and a set of probes makes electrical contact to the pads on the die, which are connected to instruments that can test the die. what does thought leadership mean

    ReplyDelete
  8. Great blog! This blog is very informative as I got to know more about formulation development india. Thank you for sharing! Keep writing...

    ReplyDelete
  9. The article is very simple to be understood even by those students who are not specializing in marketing. Food, Drink & Recipe Specialist | Beverage Development | Brand Relations

    ReplyDelete
  10. Formulation Development Services: utilizing Quality by Design (QbD) principles in the development of pharmaceutical products for various dosage forms. These forms include parenteral dosage forms such as liquids, lyophilized, liposomal, suspension, and emulsion formulations, as well as topical, ophthalmic, and nasal dosage forms. QbD is a systematic approach to product development that involves designing and controlling the manufacturing process to ensure the desired quality of the final product.

    ReplyDelete
  11. Such a beautiful content, Please keep posting article like this
    ERP Software in Chennai

    ReplyDelete
  12. I find your blog quite captivating and beneficial. Ikon Remedies is Pharma product manufacturing Company in India, Our list of medicines contains over 1000+ products, making us the best pharma company in India. Ikon Remedies is one best pharma product manufacturing

    ReplyDelete
  13. I find your blog quite captivating and beneficial. Innovative is a pharma product manufacturing company . For the past decade, it has been actively nurturing communities across India and has emerged as one of the leading pharmaceutical companies experiencing significant growth.

    ReplyDelete
  14. Ikon Remedies is a pharma product manufacturing company, Specializing in tailored formulations, we boast an extensive catalog of over 1000 high-quality pharmaceutical products. Reach out today to explore our diverse range of offerings!

    ReplyDelete
  15. This is a nice information on product development department. keep sharing this kind of information.

    Visit :

    coupling manufacturers in India

    quick release coupling manufacturers in India

    camlock coupling manufacturers in India

    ReplyDelete
  16. Nurse salaries in the USA vary significantly based on factors such as location, experience, education, and specialization. On average, registered nurses earn approximately $75,000 annually, with starting salaries for entry-level positions around $50,000. As nurses gain experience and further their education, their earning potential increases, especially in advanced practice roles like nurse practitioners, where salaries can exceed $100,000 per year. Geographic regions with a higher cost of living, such as California and New York, often offer more competitive wages to attract qualified professionals. Additionally, specialized fields such as critical care and psychiatric nursing frequently come with premium pay. Benefits, including health insurance, retirement plans, and bonuses, play a crucial role in the overall compensation package. The ongoing demand for nurses across the nation suggests strong job security and numerous opportunities for career advancement. Overall, nursing in the USA can be a lucrative career path, providing financial stability and professional fulfillment.
    https://www.dynamichealthstaff.com/nurse-salary-in-usa

    ReplyDelete
  17. Usually I never comment on blogs but your article is so convincing that I never stop myself to say something about it. You’re doing a great job Man,Keep it up. we also provide service for Pharmaceutical manufacturing.For More Information visit our website.

    ReplyDelete