Many problems of Pharmaceutical Water Systems have one solution

Water systems professionals need to keep many factors in mind and implement important steps to ensure that water system have high purity. Design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations are all crucial components of a high purity water system, which water systems professionals have to bear in mind for ensuring purity.

                          

Understanding is the key

A thorough understanding of all the aspects of a high purity water system is very crucial for the reason that not having it can lead to serious issues. Not only does the organization need to deal with system downtime, which can be time consuming and expensive; they would face something most organizations loathe: product recalls.

The antidote to these problems is to know the logic of common water system designs. Just this understanding is likely to remove many of the issues associated with water systems.

How do professionals go about this? By first forming a basis for their understanding, which is that there is no generalized solution to all water system problems. This is the basis to clearing the myths and misconceptions about water systems.

Biofilms hold the answer

A thorough understanding of just biofilms unlocks the solution to most water systems. Unfortunately, most professionals sidestep this core aspect. This is entirely because most pharmaceutical systems, especially those pertaining to biofilms, are built on misunderstanding. This is compounded by the completely erroneous assumption that one principle or logic is sufficient to get rid of all problems on the issue.

The USP is the Bible

There is no single technical solution to all problems relating to water systems, but a single guide such as the USP can go a long way in helping ease the issue. Making proper and thorough reference to it, as well as implementing the right biofilms can be the perfect solutions to all problems associated with water systems. Such learning can be used as a single source that can be replicated in any system. This is also the key to achieving an event-free microbial control.

Water systems professionals can also achieve many of their desired results by gaining familiarity with water system validation and Change Control. All these go a long way in neutralizing many of the obstacles associated with water systems and bring down the rate of excursion investigations. 

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A brief understanding of the FDA General Principles on Process Validation

A brief understanding of the FDA General Principles on Process Validation

Key Takeaway:

The FDA has issued vastly improved and expanded general principles on process validation in January 2011. These build substantially on the previous issue of 1987.

The FDA describes Process Validation as "the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products".

Being a regulatory body, the FDA has assigned to itself the task of issuing guidelines to the industry on the principles of process validation (PV). FDA general principles on process validation, the latest of which were issued in 2011 replacing those of 1987, are aimed at facilitating:

• Modern manufacturing principles
• Sound science
• Risk assessment and mitigation
• Process improvement
• Innovation

Basis to the FDA general principles

FDA general principles on process validation are founded on the understanding of the following conditions:

How should product quality be ensured according to the FDA general principles on process validation?

FDA general principles on process validation of 2011 lay clear emphasis on the requirement of Quality. Accordingly, a product should show quality performance consistently in every batch and every unit.

What about PV?

Likewise, the FDA general principles on process validation tie process validation to the product lifecycle approach. In a nutshell, the lifecycle approach to PV binds product and process development to the commercial manufacturing process, and requires the process to be maintained in a state of control during routine production. The FDA believes that:

• Validation is a journey, not a destination
• Commercial production throws up more and more knowledge of PV
• In order to comprehend sources of variability and achieve an understanding of process; there is a need for comprehensive process design
• Risk management has to be built into process validation

The Three Stages of PV

According to the FDA general principles on process validation, Process Validation consists of three stages:

Implementation of FDA 21 CFR Part 11 Regulations optimizes an organization's capabilities

Implementation of FDA 21 CFR Part 11 Regulations optimizes an organization's capabilities

Key Takeaway:

On the surface, FDA 21 CFR Part 11 regulations appear confusing, but following a risk based approach to computer systems validation sorts these out, increases the organization's computer systems efficiency and reduces costs

FDA 21 CFR Part 11 regulations have been codified to ensure that companies implement good business practices into their computer systems. Implementation of FDA 21 CFR Part 11 regulations into an organization's computer systems is a sure way of enhancing the efficiency of employees, identifying risks and thereby reducing errors, and thus increasing the productivity in the organization.

Outstanding features of FDA 21 CFR Part 11 regulations

Before the advent of electronic records and approval signatures; these were being done on paper. The purpose of FDA 21 CFR Part 11 regulations is to ensure that an electronic record that replaces a paper record and an electronic signature that replaces a handwritten signature have to be authenticated. Regulatory authorities have to be convinced that these digital formats are as authentic and trustworthy as the physical ones they replace.

• FDA 21 CFR Part 11 regulations are part of the Code of Federal Regulations (CFR)
• CFR contains laws that each government agency has to fulfill
• The CFR has several titles, and each of these addresses a designated, regulated area
• Critical areas of laws under the CFR relate to electronic records and approval signatures.

Three primary areas of 21 CFR Part 11 compliance

Compliance with 21 CFR Part 11 regulations consists of three core areas:

FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 Compliance

Key Takeaway:

FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries' electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

• Medical device manufacturers
• Drug makers
• CROs
• Biotech companies, and
• Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

• Required to be maintained by the FDA predicate rules or
• Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

Going by the FDA 21 CFR Part 11 Checklist is a good way to stay on track

Going by the FDA 21 CFR Part 11 Checklist is a good way to stay on track

Key Takeaway:

It makes sense for organizations that are part of 21 CFR Part 11 to have a checklist of requirements, as this helps eliminate thorny issues.

There is considerable confusion about the requirements of electronic signatures set out by 21 CFR Part 11. Many organizations get confused about areas like the mode of signatures, as there are different requirements for electronic and paper formats of the same regulation. In order to resolve confusion arising out these and other issues, making an FDA 21 CFR Part 11 checklist is a good solution.

The benefits of charting out an FDA 21 CFR Part 11 checklist are many:

• It acts as a guideline in helping organizations comply with the requirements set out in this regulation;
• It helps to overcome oversight, as there is a fairly high possibility of its occurrence;
• It helps to put necessary and appropriate regulatory requirements and standards in place to tackle the huge list of requirements in this regulation.

Going by this checklist is of immense value to organizations

The numerous advantages of EHRs notwithstanding; some concerns abound about its usage.

Electronic Health Records -an understanding

Electronic Health Records -an understanding

Key Takeaway:

EHRs are a shining example of the advancements being made in the technology the American healthcare system uses. They need to be comprehended properly to facilitate their adaption.

The terms Electronic Health Record (EHR) is self-explanatory: it signifies an electronic version of paper medical records of a patient. Since these are digitized records; they are real time, with instant access and updating over all the sources and locations at which it is available. If a new value gets entered or deleted or altered; the same gets updated at all locations. This means that any authorized user having access to a patient's EHR gets the latest record, making decision-making easier and faster.

Features/advantages of electronic health records

• Electronic Health Records contain all details of a patient's medical history, such as diagnosis, medication routine, treatments advised, immunization protocols and related information
• Gives importance to processes, because of which it gives access to evidence-based tools which help healthcare providers take important decisions about a patient's care. It ensures accuracy of diagnoses and health outcomes irrespective of which medical center or healthcare professional is attending to the patient;
• In totally automating and streamlining provider workflow, EHRs make patient information instant and current across all locations, no matter in which geography that record is being accessed;
• It brings about an improvement in the quality, as well as convenience of patient care;
• Fosters increases patient participation;
• Since electronic health records are spread across the length and breadth of the country; they improve practice reduce costs.

Concerns about EHRs

The numerous advantages of EHRs notwithstanding; some concerns abound about its usage.

The EHR Incentive Program is what it is -an incentive for healthcare providers to digitize

The EHR Incentive Program is what it is -an incentive for healthcare providers to digitize

Key Takeaway:

The Centers for Medicare & Medicaid Services (CMS) are involved in a mammoth task of digitizing patient health records. They use the bait of incentives to accelerate the process while maintaining quality.

Digitizing health records is a mammoth task by any standards, considering the extent, size and nature of records that need to be made available in electronic format. To ensure that this becomes a national, pan-US activity; the federal government introduced a method by which to implement EHRs: by offering incentives to those professionals, eligible hospitals, and Critical Access Hospitals (CAHs) at various stages of adopting, implementation or upgrade, or if they have demonstrated meaningful use of certified EHR technology within set deadlines. Meeting deadlines is a very critical requirement of the EHR Incentive Program.

Criteria for being eligible for EHR incentive program

The Centers for Medicare & Medicaid Services (CMS), which oversees the EHR Incentive Program, has put forth many criteria for eligibility for EHR Incentive Programs

Thirdly, FDA 21 CFR Part 820 requires the manufacturer to establish and maintain procedures for the receipt, review, and evaluation of complaints.

What should records of investigation contain?

Records of investigation should contain the following:

• Identifiers related to the device and reported event
• If Medical Device Reporting is made, it should investigate the following:
• Whether there were any specifications the device failed to meet
• Whether it was for treatment or for diagnosis that the device was being used
• In what way the device was related to the reported event, if applicable