Market Place
In June this year, PharmaCompass
was the first to report that Teva’s newly-built
sterile manufacturing facility in Hungary had been placed on FDA’s import alert list. The FDA warning
letter to Teva, released this week, shares details of what
went wrong.
As has been seen with other sterile manufacturing facilities – such as that of Hospira
(now Pfizer), Agila
Speciaties (now Mylan) and Sun
Pharma – Teva’s facility failed to “adequately investigate media fill and sterility test failures”.
According to the FDA, “media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.”
“These failures indicate that there is a lack of adequate sterility assurance in your manufacturing facility,” the warning letter to Teva said.
Data
integrity concerns not limited to Asia
The warning letter makes it amply clear that data integrity
concerns are not limited to India and China. While data integrity concerns at
Asian companies have been hogging the news headlines, similar problems exist in
Europe too.
In the case of Teva’s Hungary plant, FDA’s investigators found “quality-related documents in a waste bin”. Investigators also found Teva’s “stand-alone computer systems” to have lacked controls (such as routine audit trail review and full data retention) to prevent analysts from deleting data.
In addition, the warning letter said that the “colony counts for environmental and personnel monitoring” did not match the plant’s official records.
“After an error was observed on the original data sheet, the record was torn and discarded with no written explanation,” the warning letter said.
All drugs produced at Teva’s finished dosage forms facility in Hungary (barring antibiotics Amikacin and Bleomycin) were
placed on the import alert list.
Data manipulation at Otsuka’s Czech subsidiary
While Teva’s facility was placed on an import alert, a Czech-based subsidiary of Otsuka
Pharmaceuticals – Interpharma
Praha, a.s. – also received a warning letter.
Interpharma, which became a wholly-owned subsidiary of
Otsuka in 2008, manufactures active pharmaceutical ingredients (APIs) and
finished products.
FDA inspectors found that while testing APIs, analysts “used to generate and analyze chromatographic data that allowed them to eliminate failing, atypical and satisfactory results with no notification; alter peak areas; and add or eliminate samples from sequences without authorization.”
During inspection, the FDA reviewed an audit trail from its “Empower-2 system that stored 8,906 entries. Of these, well over half indicated some form of data deletion or manipulation, including at least 1,441 instances of deleted results,” the FDA said.
Interpharma’s personnel confirmed “that these actions are common during chromatographic data processing.”
While reviewing the finished products at Interpharma, FDA investigators uncovered “many deleted results” which made them question whether the quality unit was “presented with incomplete and inaccurate information”.
Our three vital observations in the two cases
PharmaCompass has
made the following three observations pertaining to the inspections at Teva and
Interpharma, and their outcomes:
Both these inspections took place in Europe, as
against Asia.
Interpharma was not placed on FDA’s import alert, even though the FDA reached the same conclusion here, as it did in the case of Teva’s Hungarian plant – that the quality system did not adequately ensure the “adequacy and integrity of data to support the safety, effectiveness, and quality of drugs” it manufactures.
The most interesting observation made by PharmaCompass is that while Teva’s products were banned from entering the United States within four months of the inspection – that occurred between January 21 and 29, 2016, nothing of the kind happened in the case of Interpharma. The inspection at Interpharma took place from October 12 to 16, 2015. And in July 2016, Interpharma’s new oral contrast
reagent for abdominal scans got approved.
Does
data integrity have a relationship with product quality?
This brings us to the statement made by Peter Werth some
months back in our Speak Pharma series, which had raised the hackles amongst some in the pharma industry – that ‘Data integrity has no relationships with product quality’.
Was Werth right in saying so?
With
a large chunk of drugs and drug ingredients being manufactured outside the US,
the American regulator has had to increase its international oversight and ban
products manufactured in plants that do not meet regulatory standards. However,
these bans have led to drug shortages.
In
order to prevent drug shortages, the FDA has (sometimes) had to exempt products
and allow imports from plants that it believes have a poor record. According to
the FDA import alert records, since 2013 the FDA has
allowed eight plants whose products are otherwise banned from the US to go
ahead and import some drugs or ingredients to avoid drug shortages. Amikacin manufactured at Teva’s Hungary plant is once such drug.
However, the FDA’s exemption to prevent a drug shortage suffered a setback when Teva announced a voluntary recall of seven lots of Amikacin Sulfate injection due to the potential for the presence of
glass particulate matter. This announcement follows a similar announcement by Teva when one lot of Amikacin was
recalled in March this year. ”
Our view
With all the compliance alerts that make headlines, if
products still reach the market after regulators uncover concerns related to
data integrity, it is worth investigating the link between data integrity
violations and patient/product safety?
Impressions: 5902
https://www.pharmacompass.com/radio-compass-blog/data-integrity-concerns-in-europe-at-teva-interpharma-raise-the-drug-shortage-versus-quality-debate
#PharmaFlow by PHARMACOMPASS
27 Oct 2016
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This week, Phispers takes you through the EpiPen price hike controversy, and the Indian government’s decision not to adopt a bulk drug policy. There is more news pertaining to Teva’s divestitures, GSK’s new drug for HIV treatment and drug recalls by Cadila, Teva and Sagent. A setback to Indian pharma as minister
says govt against bulk drug policy Earlier this year PharmaCompass had highlighted the ‘inconvenient
truth about Chinese drug manufacturing’ – that a serious imbalance exists in the global supply chain with regard to its dependence on China. India had declared 2015 as the Year of the API, under the ‘Make in India ‘programme. A Cabinet note for a bulk drug policy, based on the recommendations of the Katoch committee, had been floated
earlier this year. Such a policy would have helped the Indian
pharmaceutical sector turn into a US $ 200-billion industry by 2030, and
shifted global dependence away from China.However, the plan suffered a setback as the chemical and fertiliser minister Ananth Kumar announced this week that
the government was against
a bulk drug policy. Instead, states will have to come up with “bulk drug parks” which will help boost manufacturing of bulk drugs.This news comes at a time when a Bloomberg
analysis concluded that China
drug sales grow despite safety concerns at home. Around 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw those that were false or incomplete. “Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials,” the Bloomberg report said.Currently, India is dependent on China for APIs. More than 75 per cent of India’s bulk drug imports come from China. And there is concern over quality. Mylan CEO blames system for EpiPen price hike,
announces launch of generic versionLast week, Mylan made headlines as its 400 percent price increase of EpiPen auto-injector came under scrutiny. The furor continued,
even as the Mylan CEO Heather Bresch tried her best to justify the price hikes
in an interview, which generated more negative publicity. In the interview, Bresch blamed the healthcare system for the price hike. According to her, the price of US $ 608 for the life-saving EpiPen reflects a system where there are “four or five hands that the product touches and companies that it goes through before it ever gets to that patient at the counter.” This week, Mylan tried to suppress the furor by
announcing it would launch an authorized generic version of EpiPen for half the price of the brand-name product. The identical generic two-pack of EpiPens, expected to launch in several weeks, will have a list price of US $ 300. This is still significantly higher than the price of the auto-injector prior to Mylan’s acquisition of the EpiPen in 2007. In Canada, the twin pack costs US $ 200, in France it is around US $ 100.In the interview, Bresch acknowledged that the high
retail price in the US was used to subsidize the price of EpiPens in Europe, where
they sold at just US $ 100 or US $ 150.Bresch went onto say: “Congress and the leaders of this country need to quit putting their toe in this topic and really fix this — we have an outdated system.”After the interview, pharma bad boy Martin Shkreli defended the price increase while some Americans turned to Canada for cheaper EpiPens. And Senators questioned if the FDA was to blame for the high drug prices. Meanwhile, analysts said the authorized generic
version of EpiPen may actually make more money for Mylan! Aurobindo, Intas in race to buyout UK and Irish
portfolios of TevaLast week, two Indian drug makers – Aurobindo Pharma and Intas Pharmaceuticals – emerged as the final contenders to buyout the UK and Irish portfolios of Teva. These portfolios of the Israeli generics behemoth have been put up for
sale to comply with the European anti-trust regulations.Both Aurobindo and Intas put
up binding offers of around US $ 1 billion, along with firm financing
commitments, The Economic Times
reported. Last year, Teva had acquired
Allergan Plc’s generic business for US $ 40.5 billion. Teva
is selling assets as part of a broader divestiture process to comply with the
anti-trust regulations for this acquisition.In order to comply with
these regulations, Teva has already sold 80 products in the US to drug makers
like Dr Reddy’s, Sagent, Cipla, Zydus Cadila, Aurobindo, Impax and Perrigo. Glaxo plans to shake up HIV treatment with new drugGlaxoSmithKline plans to capsize the decade-old strategy for treating HIV. Executives at GSK are hoping that the company’s latest HIV pill is powerful enough to suppress the virus, with the help of just one more drug. The drug – Dolutegravir – belongs to a class of HIV drugs known as integrase inhibitors that rapidly reduces the level of virus in the blood. It has already been approved for use as part of traditional triple therapy and hasn’t reported cases of the virus developing resistance to dolutegravir in patients who are new to the treatment.Since the mid-1990s, the treatment of HIV – a virus that causes AIDS – hasn’t changed much. In the mid-1990s, a new class of antiretroviral drugs were introduced. One drug from the new class, along with two other drugs from an earlier class, hindered the virus from developing resistance. This three-drug regimen has been the standard approach for treating HIV for the last two decades.Dolutegravir, according to GSK CEO Andrew Witty, would
be the game changer because taking fewer drugs will lead to fewer side effects.GSK’s majority-owned HIV business – ViiV Healthcare – is undergoing the long process of proving the efficacy of the Dolutegravir. Pfizer and Japan’s Shionogi & Co hold minority shares
in ViiV Healthcare. Japanese wholesaler arrested for illegally selling drugs to Chinese
touristsHidenobu Zaima, president of Tokyo-based drug wholesaler – Biken Pharmacy, was arrested along with four others, on the suspicion of illegally selling
large quantities of prescription drugs to Chinese tourists and violating the
Pharmaceutical and Medical Device Law.Zaima is believed to have sold about 291,000 products
to a Chinese broker for US $ 147,000 between September 2015 and May 2016. Chinese tourists often buy prescription and
over-the-counter products in other countries, such as Japan and Hong Kong,
where they can be cheaper. They also believe that drugs bought in these
countries would be of better quality. Teva, Cadila and Sagent recall drugsThis was a week of drug recalls in the US. Teva issued
a recall of antibiotics for the second time
this year. This time the recall pertained to amoxicillin manufactured at a plant in Canada. The
company is recalling 53,000 bottles of the drug manufactured by Teva Canada Limited in Toronto.Earlier this year, Teva had recalled amikacin sulfate manufactured at its
facility in Hungary due to the potential for the presence of glass particulate.
Meanwhile, India’s Cadila Healthcare recalled 26 batches (or 223,776 bottles)
of an antidepressant -- venlafaxine HCL ER capsules – as well as nine lots for which the company did not specify the bottle count. These drugs were manufactured at the company’s plant in Ahmedabad. The drugs failed dissolution specifications when retained samples were tested. Venlafaxine is used to treat major depressive disorder, anxiety and panic disorder.Similarly,
Sagent Pharmaceuticals recalled one lot of oxacillin for injection manufactured by India-based Astral SteriTech. The action was taken after a customer
complained that small, dark particulate matter was found in the solution after
it was reconstituted. The foreign matter found in the vials was identified as iron oxide.
Impressions: 3813
https://www.pharmacompass.com/radio-compass-blog/mylan-s-epipen-price-hike-defense-india-throws-out-plans-of-a-bulk-drug-policy
#PharmaFlow by PHARMACOMPASS
01 Sep 2016
It has been an
unprecedented week where compliance glitches have emerged from almost all parts
of the globe. This week, PharmaCompass
brings you a compilation of such troubles to give you an idea about the nature
of such compliance issues. And, the problems regulators are facing walking the
tightrope between drug safety and drug availability. Pfizer halts production in India after joint
inspection by four regulatorsPfizer recently halted production at a plant
near Chennai in India, after a PIC/S (short for Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Co-operation Scheme) joint inspection
with regulators from four international agencies, MHRA (Medicines and
Healthcare products Regulatory Agency of the UK), USFDA (United States Food and
Drug Administration), TGA (Therapeutic Goods Administration of Australia) and
Health Canada, found various quality control problems. A Pfizer spokesperson told
The Economic Times: “A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations.” The plant was
acquired by Pfizer through its US $ 17 billion acquisition of Hospira, which had run into a fair share of manufacturing compliance problems with the FDA. Over the last few years, numerous Hospira plants — including those in the United States, Europe, Asia, and Australia — received warning letters and had to subsequently issue product recalls. The same
facility in Chennai received an FDA warning letter in 2013. Pfizer’s own operations in Asia ran into problems when US FDA investigator Peter Baker uncovered data integrity malpractices at a
finished dosage manufacturing facility in Dalian (China). Teva recalls product exempted from
import alert on Hungarian facilityA little over
two months ago, Teva’s largest sterile medicines plant in Hungary was placed on FDA’s import alert list. When the alert was announced, all drugs produced at the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – were placed on the import alert list. With a large chunk of drugs and drug ingredients being manufactured outside the US, the American regulator has had to increase its international oversight and ban products manufactured in plants that do not meet the regulatory standards. However, these bans have led to drug shortages. As a result, the FDA has had to (sometimes) exempt products and allow imports from plants that it believes have a poor record. According to the FDA Import Alert records, since 2013 the FDA has allowed eight plants whose products are otherwise banned from the US to go ahead and import some drugs or ingredients in order to avoid drug shortages. Amikacin manufactured at Teva’s Hungary plant was once such drug.However, the FDA’s exemption to prevent a drug shortage suffered a setback when Teva announced
a voluntary recall of seven lots of Amikacin Sulfate Injection due to the potential for the
presence of glass particulate matter. This announcement follows a similar announcement by Teva when one lot of Amikacin was
recalled in March this year. Wockhardt back on FDA’s import alert listJust when it
seemed Wockhardt was getting its compliance act together and putting its problems behind it, its
bulk drug facility got placed on the FDA’s Red List. The bulk drug division in Ankleshwar (Gujarat) is the latest to join FDA’s import alert list, with Wockhardt’s Waluj and Chikalthana (Maharashtra) units already on the list. While
Wockhardt recently said it had received establishment inspection reports (EIR) for the facilities with observations, it also mentioned that the “receipt of EIR does not materially change the status of import alert for the concerned manufacturing units for the US market.” The bulk drug facility in Ankleshwar had received a EU Written Confirmation from the Indian Central Drug Authority for the following seven products – dextromethorphan hydrobromide, adenosine, tamsulosin, nicardipine, cefuroxime axetil, fexofenadine and ceftriaxone sodium. FDA’s warning letter to China’s Xiamen reveals horrific details of GMP deficiencies Chinese drug maker Xiamen Origin Biotech (known
as Attix Xiamen Pharmaceutical in North America) was placed on the
FDA Import Alert list in May 2016. However, it was only recently that its warning letter was put up on the FDA
website, bringing to light the magnitude of GMP deficiencies. According to the warning letter, the company “repeatedly falsified and omitted information on the certificate of analysis (CoA)” issued to customers and went to the extent of fabricating the name of an employee, which was used as a false signing authority on the CoA sent to customers.The company also included an ‘expiration date’ which exceeded the manufacturer’s labeled expiration date without any basis for the extension. In addition, the company made deceptive statements
to the investigator, who also found dirty warehousing spaces and a rodent in
the room adjacent to the warehouse.The FDA’s action in China follows an import alert which was placed on the North American operation of the company – Attix Pharmaceuticals – in Canada in February 2015. The warning letter issued to Attix Canada showed the company was packaging highly potent beta-lactam products “in a facility that is not dedicated to manufacturing beta-lactam drugs”. The practices created “an unacceptable risk of beta-lactam cross-contamination in other beta-lactams and in non-beta-lactam APIs”.An outcome of the North American inspection was a
series of API recalls in both the United States and Canada. Japanese camphor producer refuses inspection; lands up on FDA’s Red ListWhile Wockhardt got placed on FDA’s import alert list as an outcome of an inspection, Nippon Fine Chemical in Japan appeared on the dreaded Red List
for refusing to be inspected.Nippon Fine
Chemical produces pharmaceutical grade Camphor, an active ingredient (along with menthol) in vapor-steam products, such as
Vicks VapoRub. Inno Pharma’s Vitamin D drops with 75 times higher content recalled in DenmarkIn Denmark, Vitamin D drops made by Inno Pharma were recalled recently as the content was “75 times too high”. The product is marketed to infants and pregnant women in Denmark, and sold under the brand ‘Vitamin D3-draber’.The hazardous nature of the drops made the Danish Health Authority (Sundhedsstyrelsen) advise anyone who had taken ‘Vitamin D3-draber’ from Inno Pharma for a week or longer to see their doctor for a blood test to assess the risk posed to them of Vitamin D toxicity. Also known as hypervitaminosis D, this is a rare but
potentially serious condition that occurs when you have excessive amounts of
vitamin D in your body. The main consequence of vitamin D toxicity is a buildup
of calcium in your blood
(hypercalcemia), which can cause poor appetite, nausea, vomiting, weakness, frequent
urination and kidney problems.
Impressions: 7178
https://www.pharmacompass.com/radio-compass-blog/compliance-troubles-emerge-at-pfizer-teva-wockhardt-and-xiamen-origin
#PharmaFlow by PHARMACOMPASS
11 Aug 2016
Peter J. Werth, President and Chief Executive Officer, ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing cGMP quality APIs to the regulated markets, is a proponent of removing data to a data-integrity (DI) file from data history, if it isn’t linked to product quality. According to Werth, FDA is unnecessarily obsessed with data integrity issues, and pharma companies have begun to fear FDA inspections. This needs to change, Werth tells PharmaCompass.
Excerpts from the interview.
Can you tell us about your journey in the world of
pharmaceuticals?
I
began by supplying generic cough and cold APIs by setting up a chemical
business back in 1975. There was a small group of companies (first generic companies)
that mainly sold cough and cold products. These companies wanted to sell patent-expired
generics and we developed select APIs for them. There was no real FDA (US Food
and Drug Administration) approval process involved.
By 1982, I realized the generic industry would be big business and API sourcing was key to success. Since I knew the API business, my wife and I formed ChemWerth – a company that supplied generic APIs.
By
1988, ChemWerth was working with 10 American and three Chinese manufacturers.
But the generic scandal changed everything. My American partner factories gave
up the API business when new
regulations came in. Chemical plants could no longer manufacture APIs. From my
previous 11 years of dealing with China, I knew that almost all of the dosage
form factories also produced APIs. This was especially important for the
injectable grade products. By the early 1990s, ChemWerth was developing APIs
for highly toxic oncology injection drugs and many antibiotics. We successfully
introduced doxorubicin, daunorubicin, mitomycin, bleomycin, etoposide, ifosfamide and several antibiotics such as lincomycin, clindamycin phosphate, amikacin sulfate, tobramycin and vancomycin (all from China).
Today, ChemWerth represents 25 Chinese factories for about 100 products. We still represent one American API supplier along with several Indian manufacturers. We recently expanded to supply veterinary drugs and partnered with a major supplier of polypeptides and a world-class supplier of heparin and related products.
You have been working with China for many years now. When
did you first come to China and how has the Chinese pharmaceutical industry
transformed over the years?
I first went to China in 1979. During that
trip, I realized I could successfully deal with the Chinese. Most of my friends
who went to China said it was impossible to deal with them. I always thought
this gave me an advantage in China. Over the next seven years, I kept in touch
with China, but did very little business.
In 1986, I was running ChemWerth and was a
consultant with a company to help its large pharmaceutical facility produce generic
APIs. We targeted clindamycin phosphate for development, since the product had
good sales, and was off patent. It also had no competition because Upjohn
(an erstwhile US-headquartered pharma company that got merged with Pharmacia in
1995, which in turn got bought over by Pfizer) controlled all the key starting material – lincomycin
hydrochloride. Using my contacts and my ability to deal with Chinese factory directors, I managed to break Upjohn’s stronghold in lincomycin. I convinced three factories to work with me so that I could file a DMF (Drug Master File). Clindamycin became a very good product for ChemWerth and gave me reason to visit China regularly to develop new business.
In those days, factories were generally old and needed upgradation. Documentation was always good, and in detail. However, it was mostly in codes and therefore useless to most others. It was extremely difficult to convince the factory to provide a true and detailed process to ChemWerth to file a DMF with the FDA. There is still a tendency (amid factories in China) to hide important facts. As a result, it takes ChemWerth at least three versions/iterations before we think we have got the right process details.
Today, the hardware in China’s pharmaceutical factories is excellent, and is usually purchased from the best overseas manufacturer. The software is good too and is likely to improve drastically as manufacturers realize software is equally important as hardware.
In view of the current GMP concerns being uncovered at
Chinese companies, are you still focused on China as a source of
pharmaceuticals?
In my mind, and in the ChemWerth representative factories, there are no
GMP concerns, no quality concerns, and no data history concerns. The FDA's
fascination with data integrity focuses on a problem that does not exist in more
than 90 percent of the pharmaceutical factories. There are at least 18 reasons
to remove data from data history. All of these 18 reasons are related to
analyst error and equipment failures (laboratory gross errors) and not related
to quality or GMP manufacturing. (Click here to read Werth’s 18 reasons to remove data).
I agree that gross errors/laboratory gross errors should not be deleted. I also agree that deleted gross errors/laboratory errors not related to quality do not deserve a warning letter.
However, the FDA should also know the main reason data is deleted is because the analyst (often) knows the result is not correct for reasons not related to quality (gross errors/laboratory gross errors). They do not want to conduct an expensive, time-consuming, and cumbersome OOS (out-of-specification) investigation. Therefore, they delete the data, weigh out new samples, fix the problem, analyze, and either receive acceptable results or rejection results.
Today, China has the most modern manufacturing facilities and the money to invest in software to manufacture the highest quality with the best traceable records. The Chinese need to trust the FDA to treat them fairly and not rely on two and three-year-old DI information. They will do the job correctly now and in future. But they cannot change the past. As stated earlier, all DI product-related observations have proven that the product quality and product history were acceptable.
China can only become a stronger API supplier. China’s volumes will increase and costs will decrease, because the domestic market is growing rapidly. The country will have cost/pricing pressures and will need to concentrate more on the difficult products that require expensive equipment. The standards set by the China FDA (CFDA) match the US FDA standards. And this will make it easier to operate under one quality and documentation system. Most importantly, they have the money to invest in the latest technology, best scientists, and equipment.
In your view, what can pharmaceutical regulators and the industry
do differently in order to communicate that the product quality is not at risk,
given the environment where data-integrity violations have become commonplace?
The FDA needs to understand that DI has no relationship with product quality. We have two recent examples. In the first case, DI issues applied to 70 batches. All 70 batches were retested and all were found to be in specification. The second case gave the same results – between two inspections over 100 batches were considered potentially fraudulent. All 100 batches were retested and were found to meet the specification. At both the factories, the data history showed all the batches are in specification – this implies 100 percent correlation to quality. The data integrity listed 100 batches and no batch failed specification – this shows 0 percent correlation to quality.
From a DI perspective, FDA inspections in factories that only produce APIs for export should be different from inspections in pharmaceutical companies that export APIs and dosage form. In reality, API manufacturers cannot cheat. They sell their product to dosage form manufacturers, which in turn are responsible for the quality that goes into the dosage form.
Off specification batches will be rejected and returned to the API manufacturer. While inspecting factories’ customer complaint file, it is rare to find batches being rejected and returned to the factory. The same does not apply to pharmaceutical companies that produce both API and finished dosage. They can hide information. Data integrity is more of an issue with companies that manufacture both API and dosage form.
What steps is ChemWerth taking with its partners in China
to improve compliance standards?
ChemWerth is addressing this issue with the FDA and ChemWerth representative factories. In broad terms, data history should be paramount, since it is related to product quality. Data integrity is a part of data history. ChemWerth has prepared a standard operating procedure (SOP) to handle electronic data.(Click here to read ChemWerth’s SOP). A simple version is that when one or both samples are out-of-specification, the analyst’s supervisor (who committed the error) reviews the data with the analysts. If they determine that one of the 18 reasons for analyst error or equipment failure is the cause of the failure, then this is noted. Three new samples are prepared, the error is corrected, and the samples are run and if all samples pass then these results are retained in data history and the product is passed. The previous bad result is documented and removed to the data integrity file. No lengthy, time-consuming, and expensive OOS report is conducted. This makes the procedure factory-friendly.
In the above example, if one of the three new samples fails, then all results are retained in the data history. The batch is rejected for rework or reprocessing.
I believe the present atmosphere between the
FDA and API manufacturers is at an all-time low. The industry feels the FDA
inspectors are looking at mostly irrelevant data to prove that the factory
operates fraudulently. Factories no longer welcome FDA inspections, out of fear
of DI failure. Factories feel the FDA is using DI to point out fraud where
there is none (excluding Hisun
and Ranbaxy).
In the past, we always welcomed FDA inspections as part of doing business. We
need to get back to that time and place.
Impressions: 6153
https://www.pharmacompass.com/radio-compass-blog/data-integrity-has-no-relationship-with-product-quality
#PharmaFlow by PHARMACOMPASS
07 Jul 2016
