As an industry expert consultant (pharmaceutical, biotech, & medical device) with more than 20 years of experience, I find that one of the difficult challenges faced by many companies is in the area of investigation compliance. The industries that I mentioned in my opening are all regulated by the Food and Drug Administration (FDA) and are therefore required to comply with the regulations that govern the manufacturing and release of their products.
A quandary that many companies face is that their growth has increased exponentially (to the delight of their shareholders) but their compliance to the regulations has not kept pace with their growth. As some companies struggle to meet the rising demand for their product, one may find that compliance to sound investigational practices that support root cause(s) and corrective and preventive actions are oftentimes deficient. This deficiency derives from several factors including: Why investigate? What to investigate? When to investigate? How to investigate and document the findings which supports the root cause of the event? Let’s first take a look at “why investigate”.
Why investigate?
Investigation is mandated by both Good Manufacturing Practice (GMP) regulations —21CFR211 and Quality Systems regulations—21CFR820. Investigations play an integral part in any manufacturing process and while some companies would rather not investigate when they have a product or process non-conformance (as a result of issues I shall identify and discuss in subsequent blogs), the information that may be obtained when an investigation is carried out according to GMPs and QS regulations can prove to be invaluable to the company’s bottom line. This week, let’s take a look at the QS regulations on investigations and Corrective and Preventive Actions.
21CFR820 Subpart J—Corrective and Preventive Actions:
Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
(2) Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
The procedures shall also include requirements for:
· Investigating the cause of non-conformities relating to product, processes, and the quality system;
· Identifying the action (s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
· Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
· Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
· Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
· All activities required under this section, and their results, shall be documented.
Investigation of product or process non-conformances helps to ensure:
· The safety and efficacy of the products that you distribute to the market
· That your products consistently meet internal requirements and external customer expectations
· That existing issues of nonconforming product or other quality problems are identified and corrected
· The root cause(s) of nonconforming products or other quality problems are effectively identified and eliminated
· That with appropriate and relevant trending of data, potential nonconforming products and other quality problems may be immediately identified and subsequently eliminated.
The answer to the question “why investigate” is several-fold: it’s mandated by law; it helps to identify and resolve issues that may drain an organization’s resources; it helps to identify potential issues of non-conformance, thereby helping the organization to bring these issues to light before they become major problems.
Ultimately, the best answer that I can give to the question of “why investigate” is the one that matters most to you and I, namely, our safety. Millions of individuals each day take a prescribed or over-the-counter medication, or give such medicines to a young child or elderly parents. Or, some of us have medical devices that have been implanted into our bodies. At the end of the day, the best reason to investigate is because investigations help to ensure that these products are safe for us to use, consume, and implant!
Marie
A quandary that many companies face is that their growth has increased exponentially (to the delight of their shareholders) but their compliance to the regulations has not kept pace with their growth. As some companies struggle to meet the rising demand for their product, one may find that compliance to sound investigational practices that support root cause(s) and corrective and preventive actions are oftentimes deficient. This deficiency derives from several factors including: Why investigate? What to investigate? When to investigate? How to investigate and document the findings which supports the root cause of the event? Let’s first take a look at “why investigate”.
Why investigate?
Investigation is mandated by both Good Manufacturing Practice (GMP) regulations —21CFR211 and Quality Systems regulations—21CFR820. Investigations play an integral part in any manufacturing process and while some companies would rather not investigate when they have a product or process non-conformance (as a result of issues I shall identify and discuss in subsequent blogs), the information that may be obtained when an investigation is carried out according to GMPs and QS regulations can prove to be invaluable to the company’s bottom line. This week, let’s take a look at the QS regulations on investigations and Corrective and Preventive Actions.
21CFR820 Subpart J—Corrective and Preventive Actions:
Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
(2) Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
The procedures shall also include requirements for:
· Investigating the cause of non-conformities relating to product, processes, and the quality system;
· Identifying the action (s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
· Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
· Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
· Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
· All activities required under this section, and their results, shall be documented.
Investigation of product or process non-conformances helps to ensure:
· The safety and efficacy of the products that you distribute to the market
· That your products consistently meet internal requirements and external customer expectations
· That existing issues of nonconforming product or other quality problems are identified and corrected
· The root cause(s) of nonconforming products or other quality problems are effectively identified and eliminated
· That with appropriate and relevant trending of data, potential nonconforming products and other quality problems may be immediately identified and subsequently eliminated.
The answer to the question “why investigate” is several-fold: it’s mandated by law; it helps to identify and resolve issues that may drain an organization’s resources; it helps to identify potential issues of non-conformance, thereby helping the organization to bring these issues to light before they become major problems.
Ultimately, the best answer that I can give to the question of “why investigate” is the one that matters most to you and I, namely, our safety. Millions of individuals each day take a prescribed or over-the-counter medication, or give such medicines to a young child or elderly parents. Or, some of us have medical devices that have been implanted into our bodies. At the end of the day, the best reason to investigate is because investigations help to ensure that these products are safe for us to use, consume, and implant!
Marie
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