Month: August 2014

Is your organization a part of the food chain?

The exploding and irreversible pace of globalization has brought in its wake changes in almost all areas of human activity. Goods and commodities that were once confined to one’s local area have now started reaching out to the unlikeliest corners of the world. One of the most active and important of such items to undergo a sea change in the way it is produced and consumed is food.

What we need every few hours, and was available and restricted to local use has now smashed boundaries. Finding a Mexican restaurant in Japan or a Chinese one in Canada is common. At the base of such drastic change in the food supply chain is the need for hygiene standards.

 

A single standard for global food?

In the last couple of decades or so since the phenomenal and hitherto unseen way in which the countries and markets of the world are getting closer to each other; the need for a uniform, global standard that regulates food standards has become a critical need. Again, this is a little problematic, because food, as we know, is very varied. It is as heterogeneous as mankind. So, is having a single Standard going to make sense?

It may not, but this does not obviate the need for a pan-food supply chain, global Standard for food safety. In fact, its need is greater than ever before now, with the changed times, when the boundaries of food movement have thinned down like never before. It is with the intention of standardizing standards across the food supply chain that ISO 22000 was born.

Certification

ISO left it to The Foundation for Food Safety Certification to establish strict systems for the effective implementation and rigorous auditing and maintenance of the standard combination. It is supported by the Confederation of the Food and Drink Industries of the European Union.

Being a certification scheme, The Food Safety System Certification 22000 or FSSC 22000 comprises ISO 22000 and ISO/TS 22002-1. It sets out a number of impartial Standards for manufacturers and others in the food supply chain to ensure quality standards. At its core, it insists on the PDCA (Plan, Do, Check, Act) methodology for the food supply chain. ISO 22000:2005 sets out the requirements for a food safety management system where any organization that is part of the food chain has to demonstrate its ability to control food safety hazards. This is to make sure that food is safe at the time it is being consumed by humans.  It applies to primary producers, processors, manufacturers, food and related service providers, and product suppliers.

References:

http://www.iso.org/iso/catalogue_detail?csnumber=35466

http://www.praxiom.com/iso-22000-intro.htm

http://arcms.ie/home/health-and-safety-systems/iso-22000-food-safety-management-system/

Investigations in Pharmaceutical Water Systems

nvestigations in pharmaceutical water systems are very critical for pharmaceutical organizations and laboratories. They can mean the difference between compliance and noncompliance. In many cases, organizations can get hauled up by regulatory authorities for failing to carry out proper investigations into pharmaceutical water systems.

The most common problem encountered by pharmaceutical and biotech companies and laboratories is microbial excursions. Investigating and handling excursions is the key to success in pharmaceutical water systems investigations.

Understanding excursions

So, what are water systems microbial excursions, and why do they appear so intimidating? In the simplest terms, microbial excursions may be defined as environmental data that is at par with or above established action limits for the regulated area. This means that in samples of water that fail to pass excursion tests, there is a certain level of contamination of the water systems in pharmaceutical and biotech organizations. Of course, it has to be borne in mind that the purity expectations and requirements are quite high compared to the water normally used by humans.

Why this is so is that pharmaceutical water systems are those that are used in the manufacture of drugs and pharmaceuticals; hence, even a small deviation from the prescribed levels of purity can have a major impact on the final outcome –the drug quality.

What can be done about excursions, then?

Having said this, excursions are not necessarily evil. Understanding whether excursions are from water, soil or from humans gives a good indication of the nature of excursions, which in turn give researchers a good idea of the nature of problems in the environment around them.

In many cases, wrongly designated trigger values, use points or wrongly selected and executed sampling and testing –and seldom excursions in themselves –are the culprit. So, pharmaceutical water systems and biotechnology organizations, laboratories and utility operations need to get their sampling right if they have to get to the root of the problem. This will help them avoid the huge costs associated with wrongly carried out investigations into pharmaceutical water systems.

 

References:

http://www.who.int/water_sanitation_health/emerging/info_sheet_pharmaceuticals/en/

http://electroiq.com/blog/2003/03/a-practical-guide-to-the-investigation-of-microbial-excursions/

 

 

 

ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place.

It is all about process

Where this approach differs from the previous standard is that it improves upon it by offering an appreciably more generic structure that is readily adaptable, acceptable and applicable across virtually all sectors of the economy and sizes of organizations. Another area where it has made life easier is that it explains the requirements in plain and uncomplicated language that is shorn of Quality waffle and is relatable to people for whom it is meant –organizations’ line managers.

The customer is the focal point

The primary focus of ISO 9001:2000 is on improving the effectiveness of a QMS in order to heighten customer satisfaction by meeting customer requirements. It finds its complement in ISO 9004:2000, whose aim is improvement of the effectiveness and efficiency of a QMS by meeting interested party requirements.

Broadly, these are the steps in this methodology:

  • Step 1: Establish the responsibilities for managing the process;
  • Step 2: Define the process;
  • Step 3: Identify customer requirements;
  • Step 4: Establish measures of process performance;
  • Step 5: Compare process performance with customer requirements;
  • Step 6: Identify process improvement opportunities;
  • Step 7: Improve process performance

How is a QMS built?

  • A QMS comprises of four categories of interrelated processes, which make up the process approach:
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

References:

http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm

http://asq.org/quality-progress/2001/12/standards-outlook/the-process-approach-to-qms-in-iso-9001-and.html

Medicaid Vs. Medicaid EHR Incentives

Medicaid vs. Medicaid EHR Incentives & Meaningful Use Certifications in US

The aim of Electronic Health Records (EHR) is, as we all know, to digitize the entire database of medical records of all patients across the US. One of the offshoots of the technological revolution; EHR is a brilliant step towards ensuring that medical records are not only stored safely, but are also accessible at one’s fingertips at any time and location.

The EHR Incentive Program

The federal program for optimizing paper records is called the EHR Incentive Program. A program of the CMS; this Incentive Program provides “incentive payments for certain healthcare providers to use EHR technology in ways that can positively impact patient care”. When digitization was already underway, where was the need for the EHR Incentive Program?

What does it do? 

This is what needs to be understood in relation to the EHR: it has been conceived and put in place to help EHR do more than its routine work of storing records electronically and transmitting information. The novelty of this program is that it seeks to optimize the use of EHR and ensure improved healthcare and patient care by providing incentives towards this end to vendors. Started in 2011 and available in 47 states; it will run through 2016.

What all are the components of this program?

The EHR program has been conceived with the intention of hastening the process of EHR, and more important, to ensure that it becomes more useful and meaningful. What are the ways by which this program will help augment the quality and use of existing electronic records, and what effect will it have on the stakeholders? These are what a webinar being organized by GlobalCompliancePanel, a leading provider of continuous professional education for the regulatory compliance industry, will clarify.

At this webinar, the speaker, Kosta Makrodimitris, who isthe principal for K Makrodimitris, which specializes in Health IT & BIO business development, EHealth education, Health Information policy will clarify on these new and expected stages and policies for Medicaid/Medicaid EHR Incentives. He will also take up for discussion the potential effects these stages will have across the states and the industry.

The webinar will start with an explanation of the policies that are in place and move on to a discussion of the upcoming regulations. He will then the possible way in which the EHR Incentive Program will affect vendors. He will also take up relevant US and global regulations and standards.

During this webinar, the speaker will cover the following areas:

  • Overview of Medicare and Medicaid EHR Incentive Program
  • Background for EHR and current landscape
  • Overview of Meaningful use for EHRs
  • Health Information Exchanges (hospitals, professionals and states)
  • Choosing a Program: Medicare or Medicaid?
  • Schedule & Timeline 2011-2016
  • Stage 1 Qualification and Compliance
  • Stage 2 Qualification and Compliance
  • Clinical Quality Measures and EHRs
  • Future of Health Exchanges and EHRs
  • Resources and Data Reports

ISO 14001, the world’s most Popular Standard for Environmental Management

If one were to be asked at a quiz which the most popular standard for environmental management is; the answer shouldn’t be difficult to give: it is the ISO 14001 by a long shot. In fact, since its enactment in 1996, ISO 14001 has been so popular that many think it is the only existing global standard on the subject of environmental management. What makes the ISO 14001 so popular?

The roots of this Standard can be traced to the emergence of the environment at the forefront of world forums and debates since about the early 1990’s. The enactment of this Standard was the culmination of the growing awareness of the importance of the environment among governments, businesses and the general public. As a result of the sustained efforts of environmental groups and other interested stakeholders, enactment of standards about the environment became almost an imperative for governments across the world.

What is the ISO 14001, and what does it do?

As we have seen, the ISO 14001 is a Standard for environmental management. It chalks out a set of guidelines to organizations across the globe for managing the environment, through a combination of action items that include, but are not restricted to the following:

  1. Ways by which to cut waste
  2. Means by which energy use can be lowered
  3. Adapt the growth and use of renewable resources
  4. Adapt a risk based approach to pollution prevention
  5. Impress upon organizations the need to comply with regulatory and legal requirements
  6. Make provisions for designs that are comprehensive and cover the complete product lifecycle

What kinds of organizations are required to comply with ISO 14001?

The ISO 14001 description clearly states that a broad swathe of organizations, both in the services and manufacturing sector need to comply with relevant provisions of the ISO 14001. Industrial and service organizations, public bodies and utilities in more than 150 countries around the world have accepted ISO 14001 as the Standard for environmental management.

References:

http://www.nsai.ie/our-services/certification/management-systems/iso-14001-environmental-management.aspx

Excel Spreadsheet Validation for FDA 21 CFR Part 11

Given the ease of their operations; spreadsheets find wide acceptance in a number of activities for laboratories. These include analysis, data capturing and reporting. Since these activities are part of a regulatory framework; companies using these spreadsheets need to comply with guidelines. These guidelines are set out in FDA 21 CFR Part 11, which deals with regulation of electronic records and electronic signatures. In this guideline, there are specific points about the use of spreadsheets.

More about Part 11

Part 11 applies to the following:

For spreadsheets that contain records required by the underlying predicate rules such as 21 CFR Parts 210 and 211 (cGMP), Part 820 (QSR) or Part 58 (GLP)

For spreadsheets that have records that are created, modified, maintained, archived, retrieved or transmitted in electronic form, or those that are submitted to FDA in electronic form.

What are FDA 21 CFR Part 11 compliance requirements?

21 CFR Part 11 makes it clear that an electronic spreadsheet has to meet the following requirements if it has to be compliant:

Security: The aim of setting out security requirements is predictable –to prevent unauthorized access to records. It seeks to make the records safe from unauthorized entry and access for the entire duration of the record’s shelf life. It sets out clear rules for user management functions.

Audit trails: Section 21 CFR 11.10(e) sets out the rules under which systems subject to Part 11 must employ audit trails. The aim of this rule is to ensure that audit trails should automatically record the date and time of all entries. These could be actions pertaining to any of these: creation, modification or deletion of electronic records. An important requirement is that record changes should “not obscure previously recorded information”. To ensure this, an audit trail for spreadsheets should include a timestamp, worksheet name, cell address, action performed, old value, new value, user ID, user name and reason for change, if applicable. It is important to note that the audit trail should not be modifiable even by the system administrator.

Electronic signatures: To ensure authentication of electronic signatures, 21 CFR Part 11 covers compliance regulations for three aspects: the printed name of the signer, the time and date on which the signature was done, and finally, the purpose of the signature. Under the last of these, the signer is expected to mention whether the sign was of review, authorship, approval, or for assigning a responsibility to someone else.

References:

http://us.mt.com/mt_ext_files/Editorial/Generic/8/2-2005_LabMagazine_Editorial-Generic_1131619850993_files/ENLabMag_2_05_8.pdf

 

Quality guidelines –ICH

Quality guidelines –ICH.

Short for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; the ICH is a collaborative project whose objective is to discuss scientific and technical aspects of pharmaceutical product registration. The regulatory authorities of Europe, Japan and the United States, as well as experts from the pharmaceutical industry across these three blocs have come together to form the ICH and carry out its stated objectives.

Aim of avoiding double work

The ICH essentially seeks to bring down, and wherever possible, eliminate the need to replicate the work done during the testing carried out for medicines. It seeks to harmonise and homogenise all the steps needed for research and development of new medicines in these three regions, so that costs come down and more effective ways of testing for and producing medicines can be brought about.

Quality guidelines

ICH has guidelines on Quality, as it has on other aspects such as safety, efficacy and multidisciplinary aspects. It has been issuing Final Guidance Documents for nearly two decades now. The ones pertaining to Quality come under guidelines whose names start from “Q”, symbolising Quality. Depending on their order, these guidelines bear titles that start from “Q”. So, Quality Guidelines start from Q1A and go on adding alphabets for additions into the guidelines.

From November 2005, the ICH Steering Committee has been implementing a new codification system for ICH Guidelines that it adopted that month. This is done to ensure that there is greater logic, consistency and clarity in the numbering/coding of ICH Guidelines.

As of now, this is how the codified guidelines for Quality, as laid out by the ICH, look:

• Stability Q1A – Q1F

• Analytical Validation Q2

• Impurities Q3A – Q3D

• Pharmacopoeias Q4 – Q4B

• Quality of Biotechnological Products Q5A – Q5E

• Specifications Q6A- Q6B

• Good Manufacturing Practice Q7

• Pharmaceutical Development Q8

• Quality Risk Management Q9

• Pharmaceutical Quality System Q10

• Development and Manufacture of Drug Substances Q11

• Cross-cutting Topics

References:

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf

http://www.ich.org/products/guidelines.html

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm

http://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use

FDA Guideline on Process Validation

FDA Guideline on Process Validation.

Process Validation (PV), as defined by the FDA, has undergone a change from the past 25 years or so. The meaning of PV is what the FDA assigns to it. So, any understanding of PV has to be tied to FDA’s guidelines which offer a definition of the term, as well as updates from time to time.

The previous and the latest guidelines…

The latest FDA guideline on PV came in 2011, and was consequential to the earlier one of 1987. In view of the changes in the industry, the definition of the scope of PV also changed. Earlier, the FDA described PV as the process of “…establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics”.

The guideline of 2011

Considering the insufficiency of this definition, the FDA issued another guideline, an updated one, in January 2011 to make the definition more wide-ranging. Expectedly, it is more comprehensive and emphasizes process understanding and control as a means of focusing on product quality. PV now means “the collection and evaluation of data, from the process design stage through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product”.

How is the 2011 Guideline different?

As defined more comprehensively in the January 2011 Guideline, the following changes may be discerned from the 1987 Guideline:

• There is added emphasis on process design. Risk is now incorporated into process design

• It now covers activities ranging over the entire process lifecycle, which is an ongoing program that is carried out in three defined stages

• Greater emphasis is laid on the role of objective measures and statistical tools

• Knowledge, detection and control of variability have got a greater thrust from this Guideline.

References:

Click to access UCM070336.pdf

Click to access handouts_-_morrison.pdf

Click to access white_paper_fda_process_validation_guidance_final.pdf

Good Practices on 510(K) Preparation and Clearance

Good Practices on 510(K) Preparation and Clearance.

First, a basic understanding of the 510 (K): A 510(k) is essentially a premarket submission that the medical device manufacturer makes to FDA to show that the device that the manufacturer intends to market is at least as safe and effective, or to use FDA parlance, Substantially Equivalent (SE), to a legally marketed device that is not subject to PMA. A legally marketed device is described as belonging to either of these categories: a) a device that was legally marketed prior to May 28, 1976 (pre amendments device), for which a PMA is not required; b) a device whose classification has been changed from Class III to Class II or I, or c) a device which, through the use of the 510(k) process, has been found to be SE.

The way of going about it

How do device manufacturers go about the process of preparation and clearance? They can support their substantial equivalency claims by comparing their device to one or more similar legally marketed devices.

A few good practices

Good practices on 510(K) Preparation and Clearance are mostly what are derived by experience. They are thus more of rule of thumb than any cogent law. A few good practices at preparation and clearance that companies can implement to get hassle-free approval include the following:

• Be clear about the regulatory pathway that the device needs to fulfill. Many companies make the mistake of giving too many uses from a device, which is likely to act as a stumbling block to the regulatory process;

• FDA guidelines are your Bible! Follow every step of its Guidance Document scrupulously and painstakingly.

• Follow extant standards, and keep the eyes and ears open to upcoming, amended standards.

• Have a qualified, well experienced regulatory professional to take care of the company’s 510(K) Preparation and Clearance work

References:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

http://www.mdtmag.com/blogs/2013/11/7-tips-painless-fda-510k-regulatory-submissions

GxP in Computer System Validation

GxP in Computer System Validation.

GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. The important ones among these are the heavy use of software in a wide range of medical activities, and the changing nature of computer technology, which has a deep impact on pharmaceutical devices and related products. Companies in these businesses need to ensure that the best practices in software are implemented mainly to keep abreast of the developments.
GxP in Computer System Validation has developed at a rapid pace of late because of the trend to integrate electronic records into manufacturing practices. While this has led to huge improvements as far as the speed of processing records is concerned; it has also brought in its wake a few inevitable challenges. .

Critical aspects of GxP in Computer System Validation

GxP in Computer System Validation consists of at least three extremely important aspects. One, GxP in Computer System Validation in the life sciences industry is not a monolithic and inflexible set of instructions. It consists of various rules and applications that need to be applied by companies according to their need and requirements. In other words, a generalized, “one size fits all” approach does not work for GxP in Computer System Validation.

Secondly, these validation requirements need to be implemented at various stages of the Software Development Lifecycle (SDLC). This means that medical device, pharmaceutical, life sciences and other related industries need to comply with GxP validation at every stage of development of the product.

Also, it goes without saying that compliance is mandatory. Noncompliance invites penalties, because GxP requirements set out by the FDA have the effect of the law.

References:

http://www.stsv.com/pdfs/STS_CSV_article.pdf

http://www.21cfrpart11.com/files/library/miscellaneous/pics_guidance_jan01_draft.pdf