The Most Important Compliance Best Practices You Need to Know

Drug counterfeiting is becoming a growing menace. With people buying prescription medicines online, it becomes all the more important to ensure that they are getting the genuine medicines. Counterfeit drugs are also proving to be a hit on the bottom line of drug companies as they are very cleverly done and go unchecked at first instance.

There have been several suggestions to counter this menace like use of color shifting inks, holograms and taggants as effective tools. However, RFID – Radio Frequency Identification tagging by manufacturers, wholesalers and retailers has proved to be the most effective technique in keeping a check on counterfeiting.

For more on how manufacturers are beefing up security to counter this menace read on..

Current packaging methods require the physician to write out dosage to the patient and the patient to refer back to the prescription to avoid any undue risk of over dosage. Any kind of oversight could result in loss of time and money in health care and may also in death.

Compliance packaging helps eliminate such risks by helping patients remember simple regimens such as once-a-week doses. Healthcare Compliance Packaging Council has been conducting, Compliance Package of the Year competition for over a decade now. This competition has showcased innovative ways how companies have come out with compliance packaging for medicines.

For more illustrations read on

Disciplined Engineering and project management processes help companies improve processes and techniques. This could be the key factor when one company can churn out similar products faster than it competitor. Quality, speed and cost-efficiency are the measures of success for any engineering project. But in reality, one is achieved at the expense of the other. Quality and speed can be achieved but at higher costs. Cost-efficiency can be achieved but quality may be compromised.

Quality is perceived differently by people concerned. The challenge is to meet these expectations and make the product a success. Speed also requires certain considerations with regards to process, resources etc.

How to reign in these factors of quality, speed and cost and role of regulatory acceptance read on

Bringing cost effectiveness into the manufacturing of medical devices today is the primary focus of manufacturers. Testing becomes the key for compliance with the quality system requirements. Testing has become a critical aspect when it comes to achieving the desired quality of products.

Testing includes:

• Design testing
• Verification of embedded software
• Design validation
• Critical agency testing
• Electromagnetic compliance

To know more on implementation of session based testing, read on

Good Laboratory Practice, a regulation instituted in 1978, intended to regulate non-clinical laboratory safety studies. The outcome of these studies gave researchers the insight into safety of the new molecular entities for human trials or clinical trials.

The main laboratories that were affected by the regulation were ones conducting clinical chemistry, histology and pathology, which are used to analyze the samples generated from toxicology studies.

What are the aims of GLP? What are the key differentiators from other regulations? What are the various GLP organizational roles and their responsibilities?

Corporate understanding of green compliance has been limited to complying with the regulations prescribed by the binding government agencies. They saw to it that their processes kept emissions well under the mandate or limit or eliminate the use of banned substances in their products.

Current trends in green compliance have seen corporate do things beyond the mandate. Environment friendly initiatives are finding its way into core corporate strategies. General awareness among the end users is also setting trends for companies to rework their conduct of business with more eco sense.

Corporate initiatives are driving the enforcement of regulations with more vigor. Any demand from the end user affects the entire chain of stakeholders. These trends are also helping government agencies in re-looking at their existing regulations or bring in better regulations.

More on this, with illustrations from the corporate world that has brought about this change, read on

http://blogs.harvardbusiness.org/leadinggreen/2008/08/what-compliance-means-now.html

Sanitation becomes critical when it comes to food safety. Improper sanitation may result in reduces shelf life and losses due to spoilage. HACCP enforces sanitation to reign in the possible hazards – microbiological, chemical, & physical - in the food manufacturing environment.

Sanitation involves proper cleaning of the food plant, equipments, utensils, and structure. This kind of an effort requires a good team of sanitarians who can work the hours required and handle the conditions of work. Sanitation department becomes the most important department in food manufacturing.

• Hiring the right people
• Providing requisite training
• Providing proper safety gear for the employees
• Factors to be considered when developing a sanitation procedure
• Information on different food soils and their attributes
• Information on different chemicals, their use and associated hazards
• Considerations with regards to the water to be used for the procedure
• Different cleaning equipments
• Detailed cleaning process

Sanitation is a preventive and proactive process. For more details on how to implement a good sanitation procedure read on

Background: Food contamination incidents can attract serious media coverage for days. As a result, these stay on top of the mind of consumers. This free publicity can harm the brand of the manufacturer but mostly the producer at the bottom of the supply chain who takes the hit. Bouncing back from such an incident is possible, but calls for greater investment of time and resources. Smaller players may not be able to withstand such an effort.

Various government agencies are working to bring in regulations to avoid such incidents because the resulting hazards affect the masses. U. S. Government has agencies like

• Current Good Manufacturing Practices - cGMP
• Hazard Analysis and Critical Control Points - HACCP

Food Defense Program provides the safe guard for the people, products, customers, assets and the brand of an enterprise. It aids the company’s communication of its commitment to protect the consumer and others involved from intentional tampering.

How to develop a Food Defense Program?

HIPAA – Health Insurance Probability and Accountability Act was enacted to protect the health insurance for workers and their families when they change or lose their jobs. Protecting patient’s health records becomes important for medical practitioners. In this age modern technology, this becomes all the more critical. Technology is susceptible to various risks of exposure and data security calls for significant investment. The ensuing article details 10 steps for understanding the gaps and how to get compliant for better data security.

The 10 steps that can help for better compliance are:

• Understand why computer security is important
• Make certain your colleagues and staff take security as seriously as you do
• Catalog all the information system components that interact with protected health information in your office
• Prepare for disaster before it occurs
• Make sure your network and communications safeguards are intact and robust
• Be certain you have anti-virus software and keep it up-to-date
• Understand what encryption will do and when it is necessary
• Consider chains of trust and your business relationships
• Demand that your vendors fully understand the HIPAA security standards
• Star with a plan – and the end – in mind

You have been through a rigorous FDA inspection, now what? You are handed a list of observations for which needs immediate corrective action. Responding to these observations is deemed Herculean task than facing the audit itself. The hows of responding to observations can be explained in steps as:

• Formation of committee
• Sub-committees to investigate particular committee
• Developing the response document
• Follow-up with FDA for its response on the document submitted
• Lessons learned

Its good to be compliant but companies need to look into the ground work that can make this a more productive and hassle free exercise by:

• Training its employees more frequently
• Upgrading the computer hardware to reduce on costs
• Better documentation and processes for efficiency

Spreadsheets are tools that simulate paper worksheets. Macro is a pattern that specifies mapping of input sequence to the output sequence in a pre-defined procedure. Macros also enable automation of repeat actions. Macros and spreadsheets are used in conjunction in regulated environments. Spreadsheet programs are very generic and their use in regulated environs requires preventive actions to avoid mitigate the risk due to erroneous outputs. Therefore, electronic records generated using spreadsheets must comply with 21 CFR Part 11.

The primary requirements of 21 CFR Part 11 are:

• Dedicated software for use in regulated environment
• Evaluate software add-ons that enable existing software to comply
• Bring in compliance requirements as built-in functions in the development phase

What are the current compliance problems? What it takes to bring spreadsheet applications under the purview of compliance?

• use of validated software and computer systems
• user-independent, computer-generated, time-stamped audit trails
• system and data security, data integrity, and confidentiality through limited authorized system access
• binding electronic or handwritten signatures to electronic records
• secure retention of accurate and complete electronic records

Commercially available software are generic, hence achieving compliance can be done by having:

Quality System Inspection Technique – FDA’s new approach to enforce regulation and compliance aims to improve speed, efficiency and consistency of both routine and pre-approval inspections. CDER has defined and grouped QSIT into six major systems as:

• Quality
• Facilities and equipment
• Materials
• Production
• Packaging and labeling
• Laboratory control

What do these broad headlines mean and how to implement QSIT?

• Is the new medicine effective?
• Is it better than the existing medication?
• Has it reduced on the risks associated with the current system?
• Is it safe?

Clinical trials are ventured into only after successful pre-clinical studies which involve cell studies and animal studies. The results from these studies must be approved by FDA before clinical trials are started. Companies file the Investigational New Drug Application with FDA seeking permission to go ahead with clinical trials.

• Pre-clinical Studies
• Manufacturing Information
• Clinical protocols and investigator information

Fact about clinical trials:

• All clinical trials are voluntary
• Not all clinical trials are study treatments
• Not all clinical trials studying treatments, study drugs
• Not all clinical trials study new drugs
• Very few cancer trials involve a placebo

What it takes to be a volunteer? What are the risks – benefits and know-how before accepting to be a volunteer?

Clinical trials are backed by sponsors. Several cooperative groups, department of Veterans and Department of defense are part of the list of sponsors. Pharmaceutical and biotechnology companies who have researched on those possible treatments also become key sponsors for these trials as they have to prove the efficacy of that particular drug so that they can bring to the market.

Entails the following requirements to be furnished by researchers such as:

The drug passes through 6 years of rigorous laboratory tests in cell and animal studies before it reaches the clinical trial phase. Clinical trial phase takes equal amount of time or more to ensure the drug gives the expected outcome with minimal side-effects. Taking the example of cancer treatment, during the clinical trials itself, once the drug is administered, it takes months to collect data on the effect it has on the subject. Increasing awareness about such trials and increased participation from adults can help speed up the process of bringing new and better medicines into the market.

Clinical trials provide vital information to doctors as:

People volunteer to such trials when faced with critical illness such as cancer. Most of these do not attract media attention unless there are any casualties. But there has been no such eventuality during clinical trials. These give researchers a chance to identify any deviations from the actual outcome. To protect the rights of Human Volunteers and weed out malpractices, now there are stringent laws, requirements and procedures governing such trials.

You have a new drug but how do you test its efficacy? Clinical Trials are procedures in controlled and closely monitored environments of new drugs on humans - a purely voluntary effort. These trials give an insight to the doctors about the impact of the new drug and the probability of safety when administered to a mass. A lot of counseling is involved when it comes to hiring volunteers for trials provided the uncertainty of the outcome. It takes a well informed decision by the volunteer when he/she accepts to be part of such trials.

Harvard School of Public Health and other institutions have zeroed in on Nine Risk Factors as responsible for one-third of cancer deaths across the globe. This has been arrived after studying several research papers and survey findings including WHO’s Comparative Risk Assessment project. It entails a full impact study of these factors on 12 different types of cancers based on age, gender and geography. Smoking and Alcohol consumption have been found to be the most damaging.

Department of Biotechnology (DBT) under the National Biotechnology Strategy has recommended the establishment of National Biotechnology Regulatory Authority. NBRA would consist of two wings:

• One dealing with food and agriculture biotechnology
• Another dealing with medical and pharmaceutical biotechnology

Prof. M. S. Swaminathan report recommends that NBRA can work in instilling public, political, professional and commercial confidence in the science. It aims to protect the health of people and environment by assessing risks and preventing those risks by regulating safe development and deployment of biotechnology products and processes.

U. S. Department of Agriculture’s newly proposed rule governing genetically engineered crops, including food crops engineered to produce pharmaceutical and industrial products came under severe opposition by the Union of concerned scientists. The charge is that the rule does not protect the U. S. food supply from contamination by drugs from “pharma” crops. There seems to be a contamination by way of cross-pollination or seed mixing between pharma food crops and crops intended for consumption.

Recommendations from various like minded organizations such as UCS and Grocery Manufacturers Association to ban outdoor production of pharma food crops have been ignored by USDA. The new proposal also does not offer any incentives for pharma companies to follow already existing safer methods of producing drugs.

USDA has also left a very small window for public participation in its rush to enact this rule into law.