Ranbaxy claims big pharma company behind falsification accusations

July 17, 2008

Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company’s share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.

The Indian company was seeking to allay investors’ fears that the deal with Daiichi Sankyo, which is binding and final according to Ranbaxy, would be scuppered by the accusations.

In clarifying the situation Malvinder Singh, Ranbaxy’s CEO, said he believed that the falsification claims were orchestrated by a big pharma company acting in cahoots with elements in India.

Speaking to the media Singh said: “I understand that there are rumours in the market where a big pharmaceutical company and a multinational corporation, a leading Indian company and certain stock brokers out there are trying to create uncertainty, bring the price down and take advantage of the situation.

Daiichi Sankyo and Ranbaxy deal is absolutely on track and there are no changes. The deal of Daiichi Sankyo and Ranbaxy stands, it is a binding deal.”

Singh stopped short of naming any of the parties believed to be involved but did say that Ranbaxy is currently collecting data from the market with the intention of providing relevant information to the authorities in the future.
In doing so Ranbaxy has gone on the offensive after seeing its share price fall by 23 per cent over two days. As a result of Ranbaxy’s response its stock price rose by 15 per cent.

Ranbaxy’s stock price tumble followed the US Department of Justice filing documents with a district court in Maryland covering whether Ranbaxy had falsified data to achieve compliance with US regulations.

The FDA‘s filing is the latest twist in its three-year investigation into Ranbaxy’s operations, which has seen the agency raid the company’s US headquarters and New Brunswick manufacturing facility.

Ranbaxy’s statement played down the significance of the FDA’s latest move. Singh said: “This is a motion to seek information and there is nothing beyond that. Any information they need will be sent to them in the next few days.

Our technical consultants Parexel will provide the US authorities the requisite information in the next 2-3 weeks. It is our understanding with them that this motion will be recalled once we submit all documents.

Source: Outsourcing-Pharma

India emerging as big drug market

July 17, 2008

Indian pharma companies have had to weather a series of big changes in recent times, including big pharma’s successful strategy in aggressively challenging generics. But the Wall Street Journal’s trend piece also notes that over the next decade Indians’ appetite for drugs will grow from $8 billion to $30 billion, making it an important market for the drug companies. Report

Global Audit Board Rules on Related Parties

July 17, 2008

A new rule from the International Auditing and Assurance Board focuses on the risks of fraud posed by a company’s relationships.

The International Auditing and Assurance Board has released a new standard that clarifies how auditors should treat “related parties,” which unscrupulous companies — Enron, for example — have used to distort earnings or cloak items from financial statements.

The new rule is part of the board’s ongoing “clarity” project in which it is revising many of its standards so they have more universal application. In some countries, financial reporting rules don’t specify what to do about related parties, noted board chairman John Kellas.

Related parties can be a company’s controlled entities, shareholders, or management, all of which carry the potential for fraud. Kellas called the revised standard a “recognition that fraud remains one of the areas of greatest challenge for auditors.”

The standard is not about procedures but rather focuses on having auditors look at where the risks of material misstatements associated with related parties might rest and how to respond to them, according to Kellas. The standard also is intended to clarify the auditor’s responsibilities in situations where a financial reporting framework does not have any related-party requirements.

The new standard provides clearer objectives for auditors regarding related-party relationships, outlines what related-party transactions an audit should cover, and makes clear that understanding these relationships is crucial to understanding a firm’s financial results. It also pushes auditors to take care to inspect transactions “outside the normal course of business,” anything that suggests hidden relationships, and newly established relationships.

Other standards that have been revised by the International Auditing and Assurance Standards Board (IAASB), which is overseen by the International Federation of Accountants, include those dealing with the auditor’s responsibility to consider fraud, accounting estimates, and fair-value measurements.

So far more than 100 countries have either adopted the IAASB’s rules or based local rules on them.

About ISO 13485

July 17, 2008

ISO 13485:2003 Certification is recognized as a worldwide quality certification specific to the Medical Device industry. According the International Organization for Standardization, “ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.”

The ISO certification as well as a successfully reviewed Technical File is required for a company to sell any medical device in the European Union and Canada.

ISO 13485:2003 – Requirements

  • Establishment of a quality management system for medical devices. A manufacturer must have quality procedures that are documented, controlled, and effectively implemented and maintained.
  • Ensuring that personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.
  • A detailed plan on how remedial processes will be used to assure conformity.
  • Planning and performance of regular internal audits.
  • Creating a procedure to gather feedback from customers and a feedback system to monitor emerging problems.

To understand the key success factors for risk based verification and validation planning to meet FDA and ISO 13485 requirements, Risk evaluation and development of mitigation strategies
Read More>>

ISO 13485: Auditor Training

Conducting internal audits is a large part of maintaining compliance. Training internal auditors with specialized, on-demand methods tailored to the working environment of the medical device industry is thus essential. The right auditor training for ISO 13485:2003 should focus on:

  • How to document audits and auditor interpretations
  • How to prepare checklists
  • Listening and questioning techniques
  • How to prepare Nonconformance reports
  • How to write reports

To get more familiar with the requirements of the ISO 9001:2000 quality management system standard; as well as insights useful to internal auditors in companies establishing, maintaining, or implementing and Quality Management System (QMS),  Risk evaluation and development of mitigation strategies
Read More>>

Analyzing Risk in Medical Devices is that required

July 17, 2008

Why should we perform risk analysis?

1. Risk analysis is now required by law (Revised GMP, see below)
2. Identification of device design problems prior to distribution eliminates costs associated with recalls.
3. It offers a measure of protection from product liability damage awards.
4. Regulatory submissions checklists (PMA and 510k) used by the FDA now call for inclusion of risk analysis.
5. It is the right thing to do.


“Pre-production Quality Assurance Planning Recommendations For Medical Device Manufacturers” identifies three tools for risk analysis: 1. Failure mode effects analysis (FMEA),
2. Fault tree analysis (FTA), and Failure mode effects criticality analysis (FMECA)
3. Failure Mode Effects Analysis (FMEA) and Failure Mode Effects Criticality Analysis (FMECA)

Failure mode effects analysis (FMEA) is a “bottom up” approach which assumes a basic defect at the component level, assesses the effect, and identifies potential solutions. It should be conducted at the beginning of the design effort and as part of each design review to identify potential design weaknesses. Failure mode effects criticality analysis (FMECA) adds probability of occurrence and severity of failure to the FMEA process.

The steps of the FMEA process:

• Define the function of the unit being analyzed.
• Identify all potential failures.
• Determine the causes of each failure types.
• Determine the effects of potential failures.
• Assign a risk index to each of the failure types.
• Determine the most appropriate corrective/preventive actions.
• Monitor the implementation of the corrective/preventive to ensure that it is having the desired effect.

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