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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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).