Journey of Pfizer Pharmaceutical

Pfizer Inc.  is an American multinational pharmaceutical corporation headquartered in New York City. It is one of the world’s largest pharmaceutical companies.

Pfizer ranked No. 57 on the 2018 Fortune 500 list of the largest United States corporations by total revenue.

The company develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology.

Its products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol, Lyrica (pregabalin) for neuropathic pain and fibromyalgia, Diflucan (fluconazole), an oral antifungal medication, Zithromax (azithromycin), an antibiotic, Viagra (sildenafil) for erectile dysfunction and Celebrex (also Celebra, celecoxib), an anti-inflammatory drug.

In 1849, Pfizer was founded in New York City by German-American Charles Pfizer and his cousin Charles F. Erhart from Ludwigsburg, Germany.

They launched the chemicals business, Charles Pfizer and Company, and Bartlett Street in Williamsburg, Brooklyn, where they produced an antiparasitic called santonin.

This was an immediate success, although it was the production of citric acid that led to Pfizer’s growth in the 1880s.

History :

Pfizer continued to buy property to expand its lab and factory and Pfizer’s original administrative headquarters was at 81 Maiden Lane in Manhattan.

During World War I caused a shortage of calcium citrate, which Pfizer imported from Italy for the manufacture of citric acid, and the company began a search for an alternative supply. Pfizer chemists learned of a fungus that ferments sugar to citric acid, and they were able to commercialize production of citric acid from this source in 1919. The company developed expertise in fermentation technology as a result. These skills were applied to the mass production of the antibiotic penicillin during World War II in response to the need to treat injured soldiers; most of the penicillin that were supplied to the troops  was made by Pfizer.

Pfizer acquired Warner–Lambert in 2000 for $111.8 billion at the time, created the second largest pharmaceutical company in the world.

Acquisition :

In 2002, Pfizer merged with Pharmacia and the merger was again driven in part by the desire to acquire full rights to a product, this time Celebrex (celecoxib), the COX-2 selective inhibitor previously jointly marketed by Searle (acquired by Pharmacia) and Pfizer.

On January 26, 2009, after more than a year of talks between the two companies, Pfizer agreed to buy pharmaceuticals rival Wyeth for a combined US$68 billion in cash, shares and loans, including some US$22.5 billion lent by five major Wall Street banks and the deal cemented Pfizer’s position as the largest pharmaceutical company in the world

In October 2010, Pfizer agreed to buy King Pharmaceuticals for $3.6 billion in cash or $14.25 per share: an approximately 40% premium over King’s closing share price October 11, 2010.

Plans to spin out Zoetis, the Agriculture Division of Pfizer and later Pfizer Animal Health, were announced in 2012

In February 2015, Pfizer and Hospira agreed that Pfizer would acquire Hospira for $15.2 billion, a deal in which Hospira shareholders would receive $90 in cash for each share they owned. Hospirais the largest producer of generic injectable pharmaceuticals in the world.

In 2018 Pfizer announced it would reorganise its business into three separate units; a higher-margin innovative medicines division, a lower-margin, off-patent drug division, and a consumer healthcare division, with a view to focussing on higher margin therapies.

In May 2019 the company announced it would acquire Therachon for $810 million, expanding its rare disease portfolio through Theracons recombinant human fibroblast growth factor receptor 3 compound, aimed at treating conditions such as achondroplasia.

n May 2020, Pfizer began testing four different coronavirus vaccine variations to help end the COVID-19 pandemic and plans to expand human trials to thousands of test patients by September 2020. 

In late July 2019, the company announced that it would spin off and merge its off-patent medicine division, Upjohn, with Mylan, forming a brand new pharmaceutical business with sales of around $20 billion.

 The new combined business will have a portfolio of drugs and brands including the Epi-Pen, Viagra, Lipitor and Celebrex.

Pfizer is organised into nine principal operating divisions: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, Nutrition, Animal Health, and Capsugel.

Operation :

Pfizer is organised into nine principal operating divisions: Primary Care, Specialty Care, Oncology, Emerging Markets, Established Products, Consumer Healthcare, Nutrition, Animal Health, and Capsugel.

Controversies :

Pfizer is party to a number of lawsuits stemming from its pharmaceutical products as well as the practices of various companies it has merged with or acquired.

These are as follows :
Quigley Co.,
Bjork–Shiley heart valve (Approximately 500 people died when defective valves failed and, in 1994, the United States ruled against Pfizer for ~$200 million)
Abdullahi v. Pfizer Inc and Trovafloxacin (Trovan) Controversy
Retrovirus lawsuit (A scientist claims she was infected by a genetically modified virus while working for Pfizer)
Blue Cross Blue Shield (Health insurance company Blue cross filed a lawsuit against Pfizer for reportedly illegally marketing their drugs Bextra, Geodon and Lyrica).

Warehouse Personnel Responsibilities in Pharmaceuticals

As you know in pharmaceutical industry there are various departments like Production, Quality Control, Quality Assurance, Engineering, Technology Transfer, Warehouse, Research and development and Human resource Department etc.

Refer Production Personnel Responsibilities : https://pharmaceuticalupdates.com/2020/06/23/responsibilities-of-production-personnel-in-pharmaceuticals/

Refer Quality Assurance Personnel Responsibilities : https://pharmaceuticalupdates.com/2019/01/26/responsibility-of-quality-assurance-personnel-or-quality-unit-in-pharmaceuticals/

Refer Quality Control Personnel Responsibilities : https://pharmaceuticalupdates.com/2020/05/02/responsibilities-of-quality-control-personnel/

Warehouse or Stores are the department in pharmaceuticals where Raw material (Active & Excipients) and Packing materials which are used in the manufacturing of batches shall be received and stored at required storage condition.

After final packing products are stored in Finished Goods stores of warehouse and after Quality control and Quality Assurance released products are dispatched to market.

Following are the job responsibilities of Warehouse personnel and this topic will help to the freshers as well as Experience personnel to gain some basic knowledge in Pharmaceuticals.

  1. To maintained Warehouse and Finished Goods area clean and presentable for audit.

2. To follow Good Documentation practices and safety instructions & ensure compliance while working in warehouse.

3. Receiving of Raw materials and Packing materials and Prepare Goods receipt Note (GRN)

4. Recording of Temperature, Relative Humidity and Differential Pressure in stores and Finished Goods area.

5. Arrangements of Raw material and Packing material in stores according to the status i.e Under test Approved, Rejected and Quarantine etc.

6. Dispensing and issue of Raw materials and Packing materials to production and Packing department as per respective Batch manufacturing and Packing record.

7. Filling the Equipment Logbooks and area logbooks and entries in Batch manufacturing and Packing record after dispensing. 

8. To perform the Calibration and Verification of Weighing balances.

9. Ensure compliance with current Good manufacturing Practice (cGMP) in warehouse.

10. Manpower handling in warehouse department.

11. Physical verification of stocks as per Standard Operating procedure.

12. Follow up with Quality control department for timely sampling and release of materials.

13. Preparation of Standard Operating Procedure related to warehouse department.

14. To provide SOP Training to juniors or new joining persons.

15. Responsible for Handling of Change control and Deviations.

16. Prepare packing list and dispatch plan for Finished Goods and dispatch of Finished Goods.

17. Identify the materials which are due for Retesting on monthly basis and inform to respective department for sampling of the same.

18. Handling of Damaged, Rejected and Expired materials in warehouse.

19. To follow online documentation in Raw material, Packing material and Finished Goods store.

20. Follow up with purchase and commercial department for disposal of non moving, obsolete and rejected raw and packing materials.

21. Temperature mapping in Stores and Finished Goods area.

22. Posting and Transaction of materials in SAP or ERP system.

Production Personnel Responsibilities in Pharmaceuticals

Each departments have their own responsibilities in Pharmaceutical and based up on the job responsibility every body has to work.

Job responsibility shall be assigned to the persons based upon Educational Qualification and Experience and according to the job responsibility every body has to take Standard Operating Procedure (SOP) Training.

Following are the job responsibilities of Production personnel and this topic will help to the freshers as well as Experience personnel to gain some basic knowledge in Pharmaceuticals.

  1. To maintained Manufacturing and packing area clean and presentable for audit.

2. Recording of Temperature, Relative Humidity and Differential Pressure in Manufacturing and Packing area.

3. Filling the Equipment and Instrument Logbook in Manufacturing and Packing area. 

4. Ensure compliance with current Good manufacturing Practice (cGMP) on shop floor.

5. To follow Good Documentation practices and safety instructions & ensure compliance while working in manufacturing and Packing area.

6. Operating the machines as per product requirements and Manpower handling in Production and Packaging department.

7. Filling of Batch Manufacturing and Batch Packing Record in Manufacturing and packing area.

8. To perform Daily or Monthly weighing Balance calibration or verification in Manufacturing and Packing area.

9. To procure, receive and manage all change parts, Stereos, Sieves, Screens, Finger bags, Punches, Dies etc for Manufacturing and Packing area.

10. Planning and execution of batches to be manufactured in process and Packaging area.

11. To maintain and Fill the documents online and review the documents like Manufacturing and Packing Records.

12. Review of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record and Master Packing Record.

13. Execution of process equipment qualification by coordinating with qualification team and vendor.

14. Preparation or Review of Failure investigation, Market complaint investigation, Change control, Deviation, Out of Specification and investigation routed through Quality Management System (QMS).

15. To initiate Change Control if required and Fill Deviation form in case of any Non conformance

16. Review protocols and reports for cleaning, Process validation, Mapping, Hold time study and qualifications etc.

17. To ensure for completion of Preventive maintenance as per schedule. 

18. Responsible for compliance for all types of regulatory audits , Inspection and/ or internal quality audit

19. Preparation of Job responsibility for Production and Packaging personnel.

20. Preparation of Standard Operating Procedure in Manufacturing and Packing Area.

21. To Provide SOP Training to the sub-ordinates and newly joined personnel.

22. Section wise allocation of work to sub-ordinates.

23. Ensure implementation of Pest control program at site.

24. Control of Plant Hygiene and manufacturing environment and environmental monitoring in area .

25. To ensure the completion of Monthly Training for Production and Packaging personnel.

26. SAP and ERP Transaction related to Manufacturing and Packaging department.

27. To implementation of Corrective and Preventive Action at shop floor.

28. To guide or Explain the Auditors and External persons about the manufacturing and Packing area if required.

29. To coordinate with other departments like Engineering, Quality assurance, Warehouse and Quality Control for smooth running of manufacturing and Packing activities.

Copy the above contents may be subject to copy writing and not allowed

Refer responsibilities of Quality Assurance : https://pharmaceuticalupdates.com/2019/01/26/responsibility-of-quality-assurance-personnel-or-quality-unit-in-pharmaceuticals/

Good Control and Practices in Packaging

Below are the general procedure for good controls and practices for Packaging Activities in Pharmaceuticals and the persons working in packing department should follow the procedure for better control and compliance.

Every person should follow personnel entry and exit procedure for entry and exit in Packing Area as per SOP (Standard Operating Procedure).

For SOP Pl refer : https://pharmaceuticalupdates.com/2019/02/02/standard-operating-procedure-sop-of-standard-operating-procedure-sop/

Before starting any operation, personal hygiene, product safety and area cleanliness must be checked by the concerned packing personnel.

Entries in BPR (Batch Packing Record) should be done timely and neatly and BPR should be checked for its Batch No., Batch size, Product code, Market, Shelf Life, pack size and Storage condition etc.

Ensure Cleaning and line clearance of machines and area as per respective SOP’s and ensure that the machine setting is done as per respective SOP’s.

Check the release status of bulk/semi-finished product with batch no. Weigh and verify gross weight of each container against the product label on it.

Check the Product name and batch no. on each container and bring it to respective packaging line planned for packing after line clearance.

Always load the containers of the bulk product in the product hopper in serial order/Lot wise and Attach labels of bulk containers in BPR.

Check for product name, strength, count and batch no. on dispensed packaging Material before bringing the material on to the packing line.

Always keep the packing materials of one batch in a cage trolley or in a pallet with required label to avoid mix up with other product or batch.

Remove and verify the dispensed packaging material labels for material code, A.R.No., Dispensed quantity, Batch No., Count against Packaging Material Requisition and Dispensing Record and attach the labels in BPR after verification.

All rejects observed on packing line should be kept in crates / reject bins / poly bags with appropriate status labels and at the end of batch destroy rejects as per SOP .

Persons on packing line should be vigilant and shall perform their activities with full concentration and ensure that there is streamline flow of packs on packing line with appropriate packing controls.

If required provide break to the persons working in packing line .

Packing material rejects found (if any) on the packs should be informed to the line executive/technician and ensure that all the rejected packs are put in the crates.

Ensure that individual carton is checked for proper overprinting quality on it and ensure that a set of cartons per insertion into the shipper (can vary as per the shipper fill value).

Ensure that individual filled shipper is weighed for its fill value and is stacked on the pallet and ensure that if the balance detects short or excess carton on display it should be informed to the line executive and ensure that shipper number and weight is properly written on the shipper.

Initial checks and operating specifications shall be check and record in BPR as per instructions mentioned in BPR.

Reconcile all packaging material after sample quantity written by QA in BPR at the end of batch.

If any excess packaging material is required for the batch, shall be issued from warehouse and Balance packaging materials (if any) are returned to ware house through Packing Material Return Note.

If there is any partially filled shipper in the department at the time of closing, it shall  be sealed partially with BOPP tape and It shall be kept on table and It shall be checked by Officer next day morning before starting the line.

End of batch / Partial packing of batch shall be transfer to finished goods warehouse through Packed Goods Transfer Note.

For any breakdown of equipment or maintenance give the intimation to the Engineering Department.

If any cancellation is to be done in any packing document, It should be strike off by a single line and it must be signed with date by concerned person and Overwriting is not permitted in any document.

Any incident or deviation shall be immediately reported to QA by logging it and the same shall be investigated through incident report.

Usage and cleaning logs should be maintained for all the equipment.

Guideline for closing of Blister packing lines during breaks (Tea/Lunch/Dinner):

Ensure that product is not present on the sealing station of machine and the packs are removed from the machine conveyor.

Ensure that hopper and bowl are covered properly and Put off the machine.

Ensure that product fallen down (if any) on the floor are removed and put in rejection bin and ensure that the poly bags containing products are tied or fastened properly.

Put off the conveyor belt and Check the good packs/rejected packs are kept properly in the respective containers and ensure that filled cartons are overprinted.

Ensure that there are no partially filled cartons on the conveyor/table and  Put off the lights of the area and Finished goods are transfer to Warehouse as per packed goods transfer note.