Question 51:
Are you duplicating your testing efforts?
Best Answer: Our tabulation observed that companies which get warning letters are duplicating efforts. Since duplication of activities adds to costs of a manufacturing unit, it is worth asking why companies need multiple testing of the same product.
Is duplication done because there is a lack of confidence in the manufacturing process? Could this be the reason why “test” or “trial” injections are performed to ensure the “actual” result will pass when GMP documents have to be completed?
Or could it be that there is a big gap between the commitments made to regulatory authorities and the actual process being performed on the shop floor?
If your company is making these mistakes, look at how to reduce duplication of activities. Elimination of duplication improves compliance and also brings about cost efficiencies.
Question 52:
Does your company lack real-time documentation?
Best Answer: Several companies that faced regulatory action last year did not document operations in real-time. Why go through the added effort to duplicate documentation once the activity has been completed?
Are the questions which need to be answered the same as those for duplicate testing? Is it also a possibility that companies are not manufacturing the product but only manufacturing paper?
Question 53:.
Do you have problems configuring audit trails?
Best Answer: Problems with audit trail configuration were the most frequent observation made by the FDA. Interestingly, the observation was made across brands of software and equipment, reinforcing the fact that the problem had more to do with improper set-up than access to the appropriate solution.
The right configuration is important to track audit history, especially in organizations with multiple operators and administrators. How should companies configure audit trail functions in any software used to acquire data that can impact product quality?
This is definitely an area that companies need to address.
Question 54:
Are you getting to the root of quality failures?
Best Answer: In many cases, where products routinely failed quality standards, the FDA inspectors found the firms had not conducted thorough investigations to get to the root-cause of the problem.
Do companies differentiate between a one-off product quality problem coming from the manufacturing line and a recurring process failure with the potential of dispatching a contaminated product to the market?
Without a thorough investigation that gets to the root cause of failing a quality standard, no company can hope to be GMP compliant.
Question 55:
Have your employees been adequately trained for inspections?
Best Answer: When inspectors arrive on site. That’s a common observation and employees definitely need training to handle regulatory inspections.
Necessary qualifications' mean having the education, training, experience and skills or any combination of these elements that will ensure that staff can perform assigned duties and functions at an acceptable level.
However, before you begin training employees for rigorous interviews from inspectors, check if your training procedures are effective, whether or not your GMP procedures are overly complicated and if employees are following common unwritten practices?
Lack of proper employee training can be detrimental to the image of your company, as employees often end up giving ill-informed answers to inspectors. Remember – regulators are just doing their job. They have a governing body to answer to. They will report issues they find weighty and incompliant to GMP and quality norms.
Question 56:
Appropriate controls for electronic documents such as templates should be implemented. Are there any specific requirements for templates of spreadsheets? H+V February 2011
Best Answer: Templates of spreadsheets help to avoid erroneous
calculations from data remaining from previous calculations. They should be
suitably checked for accuracy and reliability.
They should be
stored in a manner which ensures appropriate version control.
Question 57:
What type of accuracy checks are expected for the use
of spreadsheets? H+V February 2011
Best Answer: Data integrity should be ensured by suitably implemented
and risk-assessed controls. The calculations and the files should be secured in
such a way that formulations are not accidentally overwritten.
Accidental input of an inappropriate data type should be prevented or result in an error message (e.g. text in a numeric field or a decimal format into an integer field). So-called 'boundary checks' are encouraged.
Question 58:
What measures are required to ensure data security of
databases? H+V February 2011
Best Answer: Data security includes integrity, reliability and
availability of data. During validation of a database based or inclusive
system, consideration should be given to:
·Implementing
procedures and mechanisms to ensure data security and keeping the meaning and
logical arrangement of data;
·
Load-testing, taking into account future growth of the database and tools to
monitor the saturation of the database;
·Precautions
for necessary migration of data at the end of the life-cycle of the system.
Question 59:
At which phases of the system life-cycle is risk management recommended? H+V February 2011
Best Answer: Risk management should be applied throughout the whole
life-cycle. A first risk assessment should be performed to determine the GMP
criticality of the system, i.e. does the system have an impact on patient safety,
product quality or data integrity?
User-requirement specifications are usually developed with
consideration of potential risks and form the basis for the first formal risk
assessment. Complex systems should be evaluated in further more detailed risk
assessments to determine critical functions.
This will help ensure that validation activities cover all
critical functions. Risk management includes the implementation of appropriate
controls and their verification.
Question 60:
Are user requirements needed as part of the
retrospective validation of legacy systems? H+V February 2011
Best Answer: The way to check whether a computerized system is fit for
its intended purpose is to define user requirements and perform a gap analysis
to determine the validation effort for retrospective validation. These user
requirements should be verified.
“Trust but Verify “ Ronald Reagan
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