Susan Schniepp and Andrew Harrison discuss the requirements for a successful corrective action and preventive action (CAPA) system.
Q. I work for a contract manufacturing organization (CMO) and am responsible for hosting audits and preparing the responses to an FDA observation. I have received multiple comments on my CAPA system from many groups, many with different perspectives. What are the real requirements for a successful CAPA system?
A. You can take comfort in the fact that you are not alone in this predicament. We consider investigations to be the cornerstone of any CAPA system and based on the data in the FDA database. FDA 483 citations are commonly issued for inadequate, incomplete, and undocumented investigations.
For some reason or another, the industry tends to focus on the immediate correction to the non-conformance. Consequently, this failure to investigate often leads to a lack of executing the corrective and preventive actions in an effective and timely manner.
Corrective Action
Basically, we need to view CAPAs as improvements we make to our processes and procedures to eliminate non-conformances in our products. These improvements are based on the results of the investigations into the non-conformance for root cause. Once the root cause is determined, then a corrective action is identified and implemented into the process.
The change is then monitored during a period of time to determine if the proper root cause was identified and if the corrective action was effective (i.e., effectiveness check). In some cases, the root cause analysis may reveal a potential for an objectionable situation to occur resulting in compromised product. The solutions chosen to avert predicted non conformance are preventive actions.
Corrective Action Plan
The key to any CAPA system is the initial investigation into the non-conformance to determine the root cause. However, not all investigations are the result of a non-conformance and not all investigations will result in a CAPA. It is important that the investigation be thorough and complete before the CAPA is initiated and implemented.
The investigation process should make use of root cause analysis tools designed to examine the impact of various process inputs and their effect on the non-conformance. These tools examine the impact of the equipment, process, people, materials, environment, and management on the identified non-conformance.
Corrective Controls
In some cases, depending on the nature of the non-conformance, some areas can be eliminated as having no impact. The rationale for elimination, however, should be documented. As the elimination process progresses, the investigation will naturally and logically hone in on the root cause(s) of the non-conformance. Once this is completed, the actual CAPA can begin.
If we look at the CAPA system as an expressway, the immediate correction and the investigation are the on ramps, the corrective and preventive actions are the lanes, and the effectiveness checks are the off ramps. The immediate correction and investigation into that occurrence should determine if the non-conformance is a one-time occurrence or if it has happened before.
Root Cause Analysis
If the non-conformance has happened before, the investigation needs to be conducted to determine the underlying root cause. Once the root cause has been determined, the corrective action and the preventive actions can be implemented and monitored. Additionally, if the non-conformance does not recur in a specified time frame, the CAPA can be closed.
Background Investigation
The bottom line is there are many perspectives on what constitutes a good CAPA system, but the reality is the quality and thoroughness of the investigations ultimately drive the effectiveness of the CAPA. When conducting the investigation, it is important not to jump to conclusions on what caused the non-conformance.
The investigation should use root cause analysis tools and should address why potential areas are either eliminated as the root cause or are a potential cause of the non-conformance. Finally, if you can conduct a complete investigation, you will ultimately have a robust CAPA program.
Article Details
Pharmaceutical Technology
Vol. 39, No. 8
Page: 78
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Q: I am a quality professional in charge of investigations. Sometimes our company has trouble coming up with the root cause for some of our investigations. Can you provide some advice on how to effectively determine root causes for our investigations?
A: You aren’t alone in your concerns regarding the inability to identify the root cause when performing an investigation. The regulations for the United States and the European Union require investigations to be performed when deviations in the manufacturing process happen.
The ultimate goal of these investigations is to determine why something went wrong, what caused it to go wrong, and how to address the issue and prevent its recurrence. The analysis is simply a systematic problem-solving approach used for determining the cause of a deviation that occurred during processing and identifying solutions to prevent reocurrence.
Root Problem
The following are a few general considerations to keep in mind while considering root problem and conducting investigations:
- One size investigation doesn’t fit all situations. Simple errors require simple documentation while more serious deviations require broader investigations.
- The best tool to have is inquisitiveness. Ask yourself how far this deviation could extend.
- Widen your perspective. Look for ways to relate, not separate, similar issues.
- Human error is rarely a sufficient cause.
- Always verify information or your instincts and never assume you are correct without proper data to support your instincts.
- Applying these general rules throughout the investigation should help you get to the true cause of the deviation.
Root Cause Analysis
Once you have recorded the basics of the deviation, you can begin the root cause analysis portion. Many tools can assist you through this process. Choosing the right analysis tool is crucial in assuring the process ensures the true root cause has been identified. Keep in mind there is no one right tool to use for analysis, and the tool you choose does not need to be complex to achieve its purpose.
Some of the available tools include brainstorming (e.g. 5why analysis, the 5whys, 5 y’s analysis), flowcharting, and fishbone diagrams. Using some or all of these tools in combination during an investigation is practical and necessary. Most investigation teams start off with the brainstorming technique.
5 Why’s
The primary concept behind the 5 Whys is simply asking you and/or your team the question “Why?” five times. This technique is ideal for flushing out root issue theories about the deviation. However, it may not be ideal for compiling the data needed to prove the correct root cause has been identified.
Using the 5 Whys or the fishbone diagram in conjunction with brainstorming adds assurance you have found the true root cause. Further, gathering the supporting data should help you validate the process and if your answer is correct.
Determining Root Cause
Root cause analysis tools can be detrimental to the outcome of an investigation if they are improperly used. It is important to train people on the proper use for a root analysis. The information needed for identifying root causes in any investigation should be appropriately documented.
The first piece of information to be recorded should be a thorough and precise description of the event. A timeline that discusses the process up to the time the deviation occurred should be established in the root cause tree.
Corrective Action
Once the event and timeline are properly recorded, a number of questions should be asked during root cause problem solving. For example, each investigation must address the following elements to ensure the true root cause and corrective action is identified:
- Historical evaluation; have we seen this before on this or other products? Have we seen this before on this line? Have we seen this before with these operators?
- An evaluation of the process or methods used by the Operations team
- An evaluation of the materials used during the operation
- An evaluation of the equipment/instruments used during the operation
- An evaluation of the personnel involved
- An evaluation of the laboratory analysis associated with the operation
- A review of the validation information for the operation.
Root Cause Investigation
Whatever tool/tools you use to identify the root cause of the problem, they need to be supported by a robust, well-documented investigation. Some of the critical elements needed to be addressed in the root cause investigation include a clear, concise description of the issue that delineates what happened. Additionally, when it happened in the process and an accounting of who was involved or observed the incident is also critical.
In any case, other information to be addressed in the investigation is a record of the immediate action that was taken to contain the situation. The investigation should be broad so that all possible causes of the deviation can be captured and evaluated as the possible root cause.
Root Cause Corrective Action
Finally, investigate all possible causes so they can be properly eliminated and reveal the systemic root cause. Remember that there could be multiple answers to find the root cause. If you keep these investigational elements in mind and thoroughly document the investigation, you should have no trouble identifying the true root cause of a deviation. Further, your team can apply the findings from the root cause tools and implement corrective action needed.
Article Details
Pharmaceutical Technology
Vol. 43, No. 2
Page: 54
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Good Manufacturing Practice (GMP)
Maintaining good quality control practices throughout the entire manufacturing process requires robust GMP development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.
Good manufacturing practice (GMP) is established by regulators to ensure that pharmaceuticals are safe and effective for the patients that rely on them.
21 CFR Parts 210 and 211
In the United States, requirements governing finished pharmaceutical quality are described in the Current Good Manufacturing Practices (CGMPs) regulations established by FDA and published in the Code of Federal Regulations (Title 21 of the CFR, parts 210–211 for most finished pharmaceuticals).
FDA also publishes guidance to further describe recommended practices for complying with the CGMP regulations. The agency states that “CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations” (1).
Quality Management
In Europe, GMPs are defined by the European Commission in EudraLex–Volume 4–Good Manufacturing Practice (GMP) guidelines (2), which were first published in 1989.
EudraLex states that quality management is “a system of marketing authorizations [that] ensures that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality, and efficacy” (2).
GMP Certified
To harmonize GMPs and other quality requirements worldwide, the International Council for Harmonization (ICH) works with international regulators and industry to develop common guidelines across the industry to ensure consistent quality expectations worldwide.
“At its core, CGMP is a science- and risk-based focus on assuring drug quality. As described in ICH Q10, Pharmaceutical Quality System, an overall attitude to drive meaningful and continuous improvements from the quality unit and other manufacturing employees is essential” (3), FDA told Pharmaceutical Technology.
GMP Manufacturing
The global nature of the pharmaceutical supply chain requires regulatory agencies to inspect and govern GMPs at manufacturing facilities. These inspections sometimes result in actions by regulators (e.g., FDA 483s, warning letters, import bans, and court actions) against companies that fail to follow GMPs.
Common CGMP deficiencies cited by FDA in warning letters sent to pharmaceutical companies inspected during the past year include failures to ensure product sterility, ensure data integrity, create quality control units, and develop and follow written procedures (4–7).
GMP Practices
“Companies should vigilantly encourage GMP practices that reflect the most current and robust methods of processing and control, and with a focus on providing a quality product to US consumers,” says FDA.
“The approach to successful CGMP is not merely a check-box approach where a single obstacle can be identified, nor is it meant to be unchanged throughout the life of a product or a CGMP facility. Using a holistic and quality risk management approach, a manufacturer can select and study specific products and processes with the goal of continual improvement of product quality and quality systems and widespread optimization.”
Quality Culture
So how do companies ensure they are “vigilantly” following GMPs and avoid the wrath of regulators? The answer appears to be found in a company’s “quality culture” and in the development, writing, and following of written procedures. Performing pharmaceutical manufacturing according to GMPs involves a dedication to quality throughout development and manufacturing processes.
“Corporate management plays a vital role in this endeavor by establishing a commitment to quality, which includes providing sufficient resources and oversight for manufacturing operations. There are many elements to successful implementation of CGMPs but measuring and monitoring quality indicators and managing change are key among them,” says FDA.
GMP Certified
According to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, becoming GMP certified throughout all processes and procedures involves a combination of personnel training, keeping tools and equipment updated, having a strong quality unit, and developing a quality culture at all levels of the company.
“How the company goes about achieving this objective is what is critical. Traditional training may not be enough. There should be constant on-the-job training and oversight on a continual basis. Upgrading tools and equipment, especially computer-driven programs, needs to involve IT departments and adhere to the current data integrity concepts,” says Schniepp.
“No one element will be able to sustain GMPs. All the elements work together to establish a culture where sustaining GMPs is a priority.”
GMP Facility
Chris Moreton of FinnBrit Consulting agrees. “Too often, in my experience, certain factions in an organization think that quality is someone else’s responsibility. There may be an organizational chart that shows where the quality unit sits in an organization, but ‘quality’ (including GMP) is everyone’s responsibility within an organization; from the most senior to the most junior and vice versa.”
Management is key in creating a quality culture, says Moreton. “If the staff see the managers taking an interest and checking on things on a daily basis, the staff will respond, and they will try harder to get things right.”
Regulatory
A commitment to staying current with regulatory expectations is a must, according to Schniepp, and she warns that complacency is the biggest obstacle to maintaining GMPs.
“Once a process or procedure is established and functional, there does not seem to be the impetus to update and revise it as regulatory interpretation and understanding changes. This leaves the process or procedure compliant to outdated standards,” Schnieep says.
GMP Audit
Companies must also learn from prior mistakes, according to Mark Lynch, vice-president of Strategic Compliance. “It’s best to take the lessons learned from product experience and apply them to the culture overall so those lessons only need to be learned once. Those experiences should be continuously applied on the product level, and also used to make improvements to standard operating procedures (SOPs), policies, personnel, and technology.”
Problem solving is another technique that must be honed, according to Lynch. “Companies must also pay continuous attention to problem identification, solution, and improvement. Refinement of problem-solving techniques contributes to organizational learning.”
FDA cGMP
Enforcing quality procedures through a policy that ties failure to follow procedures with grounds for dismissal and using internal audits to detect improper performance are options to ensuring a quality culture, according to Lynch. “It is also important that tools are a regular topic of discussion with operators to capture improvements and assure consistency.
Additionally, sufficient supervisory presence and oversight are key both for monitoring purposes, and to be sure operators can raise questions and get the support they need. Finally, it’s best practice to put a GMP standard reporting mechanism in place that does not require identification, so employees feel comfortable flagging an issue without fear of blame,” he says.
GMP Quality
Companies who do not consistently maintain GMPs may find themselves under additional scrutiny by regulators for repeat offenses. A variety of FDA warning letters have pointed out repeat CGMP violations at companies and/or a particular facility (8, 9).
FDA reports that the agency, “… strives to provide clear guidance to companies proactively and in its enforcement actions. Where repeated violations have been found at the same facility or among different facilities of the same firm, we highlight those violations so that they may be addressed adequately.
Corrective Action
A focus on a commitment to quality is essential to correcting repeated violations, as are adequate corrective actions and procedures. While we generally encourage a focus on overall quality, there are times when we encourage firms to take specific actions, which are included in our warning letters as well as in applicable guidance documents and regulations.”
Repeated offenses may be a failure to look at the big picture and apply solutions across all systems and/or products, according to Schniepp. “Companies think in terms of solving the individual citation but fail to take that answer for change to a global look at fixing other processes and procedures that might be susceptible to the same observation. Tunnel vision when responding to warning letters has a great potential to result in repeat observations,” says Schniepp.
FDA Warning Letter
“Some of these ‘repeat mistakes’ are found to be FDA violations of the same section of the regulations but stem from a different problem. Investigators tend to use repeat findings as a way to point to simplified trends that make one issue appear to be really bad, rather than the complex combination of issues that it truly is,” Lynch says.
“Some companies lack the staff, procedures, capability, and time to fully investigate and solve problems, so they pick something (e.g., a personnel error), close the investigation, and move on to release product, and the same issue reappears because it wasn’t solved.”
Risk Management
Risk management and general cost increases can be another factor to repeated offenses, according to Moreton. “Often cost and/or short-term shareholder interests are used as an excuse to avoid some measures [to long-term change] … People complain that quality costs money, but if they really want to see how expensive things can be, they should try a consent decree.”
SOP Procedures
The lack of written procedures and/or a quality unit is another frequent infraction identified in warning letters. From October 2016 through September 2017, FDA issued more than 400 FDA 483 observations for a lack of written procedures or written procedures that were not fully followed (10).
Quality Program
Written procedures are key to a robust quality program, according to FDA and industry experts. FDA believes that the “most effective quality assurance (and compliance) strategies begin with robust internal procedures to adequately design and maintain a robust operation, and that can quickly identify and correct manufacturing problems when they occur.”
GMP Best Practices
What are best practices for developing written procedures for GMPs? While the agency does not endorse one particular approach to developing written quality procedures, FDA notes that these procedures should “be written to effectively communicate to the users of the procedure.
FDA recommends that the style and format of procedures be accessible to users, as well as ensuring adequate coverage of its purpose. We recommend that the effectiveness of a procedural training program be evaluated to ensure that personnel learn and can follow the procedures as intended.”
GMP Compliance
The trend in a GMP compliance failure to have written procedures is disturbing, according to Schniepp. She suggests that outsourcing quality, especially for start-up companies, may add to this problem. She questions whether outsourcing companies have the processes and procedures in place to handle new products.
Manufacturing Operations
A robust sharing of information between client and contract manufacturing organization is also key, including product and process understanding. “We need to also remember that new products, particularly in the biotech segment of the industry are novel in nature so the old way of doing business may not be applicable. Whatever the reason the industry must focus effort on making sure there are GMP lab processes, procedures, and written instructions in place that support the release of product,” Schniepp stresses.
Having all parties involved in the GMP labeling development of written quality procedures is necessary. “Including everyone affected by the procedure and writing the procedure with their input will result in streamlined and efficient procedures, which will be easier to maintain in the long run,” says Schniepp.
Standard Operating Procedure
Standard operating procedures (SOPs) written by people not familiar with the specific operation can cause disconnects, according to Lynch. “The best way to assure adequate SOPs is to sit down with people most familiar with operations and map out the process steps and handoffs. This can be incorporated graphically using [swim lane diagrams] and similar tools like Visio (Microsoft) and include them as part of the document.”
“In my opinion, in order to ensure that quality procedures are effective, it is necessary to involve those who know the process or operation being documented,” Moreton agrees. “This may mean sitting down with the operator and finding out exactly what is being done and how, not what management thinks should be done and how they think the operation(s) should be carried out.”
Operating Process
According to Schniepp, procedures should be mapped out, committed to paper, reviewed periodically, and updated as necessary. “Companies need to remember that their processes and procedures are not carved in stone and need to be changed to stay compliant with the operations being performed and the current interpretation of regulations,” says Schniepp. New technologies and new product types may necessitate an update to procedures.
Companies should be careful to not try and fit technology or product advances into current procedures but should instead take the time to review their processes and procedures and update them appropriately in responses to these advancements, she says.
FDA Process Validation
Consistent review of GMP procedures is important, especially if a change in equipment, facility, or regulatory requirements has occurred, experts note. “Written procedures should be reviewed and updated as often as needed. However, if a process and procedure is being updated frequently then it probably wasn’t very well written in the first place,” says Schniepp.
“This being said, procedures that are fairly stable should be validated at least every two years to make sure they are still current and reflective of FDA regulatory expectations.” When developing written procedures, says Lynch, “each process and procedure should be tailored to its specific purpose, so they don’t include unnecessary steps that add time to the process without applicable value to the procedure at hand.”
SOP Documents
Companies often lack the documentation that will help operators understand the entire GMP process, says Lynch. “The most important concept to remember when writing procedures is to include the detailed instructions for the operation or processes being defined by that procedure and not include extra explanatory or extraneous information that has no bearing on the operation or process being defined,” agrees Schniepp.
cGMP Consulting
In warning letters, FDA commonly suggests the hiring of a third-party GMP consultant to help companies address their GMP deficiencies. Schniepp says these consultants can provide a “fresh perspective” when resolving GMP issues. “A new and fresh approach is valuable because the consulting firm has no preconceived ideas and can offer new insight to what may seem to be an old and uncorrectable problem,” says Schniepp.
These consultants can be helpful even when not suggested by regulators “because they are looking at the quality with eyes not steeped in the corporate culture,” according to Moreton. Consultants also have knowledge and GMP expertise the company does not have.
“[Consultants] can offer a variety of approaches and suggestions for remediating current problems as well as offering solutions to maintain and improving systems moving forward. One of the most important aspects to consider when hiring a consulting firm is to make sure they not only have the expertise, but they also have the time to devote to fixing the problem,” says Schniepp.
Manufacturing & Industrial Consultant
When hiring a GMP consultant, Moreton suggests companies look at the experience of the contractor as a whole as well as the qualifications of the individual consultants “to ensure there is a good fit with the contractee’s needs.”
Lynch warns, however, that pharmaceutical companies should not rely too much on outside help. “Consultants can help companies get back on track if companies lack the resources internally. However, eventually companies have to sustain compliance themselves. Third-parties should provide expertise in the needed area and technology and have demonstrated success.
Then, they should be able to teach and mentor personnel for improved behaviors and provide flexible models to fit company operations and culture. Usually, this is more than one-time training, but a program of measurement and support over time.”
Article Details
Pharmaceutical Technology
Vol. 42, No. 7
Pages:18–23, 60
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