Good Manufacturing Practices (GMP) and Its Role in Quality Control

Good Manufacturing Practices (GMP) and Its Role in Quality Control

There is no ambiguity about the role of Good Manufacturing Practice (GMP) in Quality Control. They are conjoined to each other at the core.

First, a basic understanding of GMP in pharmaceuticals

Good Manufacturing Practices (GMP) is a set of principles that is applicable in its own set of ways to certain fields. GMPs constitute a set of guidances that sketches and shapes the aspects of production and testing, which can have a major effect on the quality of a product.

In the area of pharmaceuticals; GMP is a part of a Quality System that covers various activities that are part of pharmaceuticals. These include medical devices, pharmaceutical products, foods, diagnostics, and the manufacturing and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients (APIs).

A word about Quality Assurance

Quality assurance is part of a Quality System, which is the sum of all individual and collective factors that go into assuring the quality of a product. It is made up of all the requirements and arrangements that combine to make the medicinal product meet its quality criteria needed for its intended use.

Now, the conjunction of GMP in a Quality System

GMP is an integral part of Quality Systems. The inseparability of one from the other can be understood from the fact that their objectives are in complete unison. A Quality System for the manufacture of pharmaceutical products needs to ensure the presence of GMP, along with associated aspects such as good laboratory practice (GLP) and good clinical practice (GCP).

In addition, the following points relate the centrality of the role of GMP in Quality Control:

  • Operations relating to production, which are quintessential for Quality Control, have to be specified clearly in a written format. GMP requirements are adopted based on these
  • GMP consists of making sure that pharmaceutical products have the right materials and in the perfectly stated dose. This is stated as part of Quality Control
  • GMP and Quality Control are linked inextricably in relation to controls, as well. Aspects of in-process controls such as validations and calibrations are carried out in accordance with the terms set out in the two disciplines
  • While the product is manufactured in accordance with set principles of GMP; subsequent stages such as processing and checking of the finished pharmaceutical product have to ensure Quality Control
  • Some activities like storage and distribution, as well as evaluations incorporate the principles of both GMP and Quality Control to ensure safety and effectiveness of pharmaceutical products.

http://www.compliance4all.com/

Advertisements

Strategic Management of Corporate Governance –the new axiom in corporate circles

Strategic Management of Corporate Governance

Strategic management of corporate governance is now a hot term in the corporate world. Implementation of this concept is being sought out by many organizations of various sizes and nature. In simple terms, strategic management of corporate governance is about putting in place a framework for laying out a clear-cut strategic plan for the organization’s operations, while at the same time ensuring that there is enhanced accountability in the organization.

Balance of profits and sustainability

A model for strategic management of corporate governance supplements the core aspect of the organization, namely quality of the product or service. Strategic management of corporate governance takes into consideration all the processes and systems and procedures needed for structuring authority and the organizational hierarchy, balancing respective roles and responsibilities by putting a system of checks and balances in place, and bringing in accountability to the organization’s stakeholders.

In essence, strategic management of corporate governance involves bringing about a healthy balance between the organization’s profitability and the way it sustains itself in the light of these aspects. It is a play of factors such as satisfying external and internal stakeholders while ensuring that ethics and accountability are maintained, even as the organization stays implements its corporate social responsibility obligations. The aim of implementing strategic management of corporate governance is to enhance the performance of the organization and take it a few notches higher.

Strategic management of corporate governance is unthinkable without stakeholders

One of the core elements of strategic management of corporate governance is the participation of stakeholders in the management process. Since stakeholders are central to strategic management of corporate governance; satisfying both internal and external stakeholders is the primary objective of strategic management of corporate governance.

Having said this, it has to be understood that as of now, there are no regulatory requirements from regulatory authorities on bringing about strategic management of corporate governance. It is a set of self-prescribed, self-directed processes.

Internal stakeholders: These are the people who are directly involved in this process, consisting of the decision makers in the organization, as well as those involved in production of the company’s product or services. So, strategic management of corporate governance has to take into consideration the factors that keep them happy and motivated. It is only when these internal stakeholders are in good mental shape that they produce better products or services, which in turn leads to greater profitability.

External stakeholders: External stakeholders consist of all those who are involved in the organization’s profits, from outside. These could be customers, investors, creditors and others. Keeping them satisfied is at the core of an organization’s business, because no asset matters as much as a satisfied customer.

Boardroom accountability: The Board level of an organization has to be held responsible and accountable for its collective decisions. One of the critical aspects of strategic management of corporate governance is to control the boardroom’s whims. The strategic management of corporate governance should ensure that the top management is not arbitrary and lacking in accountability when it comes to handling finances and other important matters of the organization.

Practicing Corporate Social Responsibility: Good strategic management of corporate governance should also take into consideration the important buzzword of today’s corporate governance, namely corporate social responsibility. This involves being involved in community work, being compliant with regulations relating to the environment, and so on. Thus, strategic management of corporate governance is a complete set of self-regulated laws that an organization has to implement if it has to show itself as being responsible to society in a larger sense and look beyond just profits.

http://www.compliance4all.com/

What are the elements of packaging and labeling in marketing?

Packaging and labeling are two important aspects of any product. They are a guide for understanding the nature of the content that goes into the product in question. In the case of packaging and labeling in marketing food products, the need for putting up clearly legible and intelligible information on the pack is of extremely high importance. Food being a critical component of our lives, wrong information can lead to several hazards.

Packaging and labelling in marketing should enable consumers to take informed decision

Packaging and labelling in marketing should serve the fundamental purpose of helping the consumer make healthy choices. Towards facilitating this goal; the manufacturer has to list all the contents of the product comprehensively, objectively, accurately and legibly.

Some guidelines on packaging and labeling in marketing

Packaging and labeling of food products becomes more effective in manifold ways when manufacturers adapt a level of commonsense, understanding its need from the consumer’s perspective.

Manufacturers could use symbols and icons to describe the nature of contents. For instance, mentioning that a food product has zero meat content in small print is one thing; putting up a picture that shows a crossed mark over meat is a far more effective practice. Haven’t we heard the age old saying that a picture is worth a thousand words?

Manufacturers that use packaging and labeling in marketing should also make the intent of their announcement with regard to content in the food stand out. Bright colored labeling is one of them. Or, even designing the product in such a way that the packaging and labeling stands out is another marketing tool.

Of course, all these have to be done keeping practicality in mind. The purpose is served when the manufacturer does packaging and labeling keeping all the important points in mind, such as the manufacturer’s name and address, date of manufacture as well as expiry, what ingredients have gone into it, how to handle the product, and so on.

the elements of packaging and labeling in marketing
the elements of packaging and labeling in marketing

http://www.compliance4all.com/

The Key Elements of the Financial Plan

A financial plan is something that is necessary for individuals, as much as it is for small businesses to multinational corporations. Financial planning is also vital for governments. A financial plan is about planning in advance for our future keeping our resources and abilities in mind. A financial plan is often the decider about whether the planner is a success or a failure.

In the context of organizational finance; one can think of six key elements that go into a financial plan. We could consider these as the core aspects of a sound financial plan:

Management of cash: This is certainly the most obvious aspect of financial planning. No planning is possible or meaningful without taking cash flow into consideration. Any person or organization has some picture about how much cash is going to flow into its accounts, and when. Though it may not always be possible for businesses to those who rely on a business for their livelihood to say exactly how much cash comes in and when; a little speculation helps. In the case of salaried individuals, it is all the easier to manage cash, because there is some certainty about the date and volume of cash that comes in at a fixed schedule. A smart, prescient saver would look at the options for saving for the future. Making lucrative investments could be a major element of financial planning. One has to use horse sense in deciding how to invest, where and how much with the limited resources. The aim should be to maximize returns to the best possible extent in the given economic situation.

Management of protection: One needs financial resources to protect oneself from disasters of various kinds. In the case of an individual, the planning has to be for unseen emergencies such as sickness. They could also be for education for children, or they could be for retirement. In the case of businesses, the organization has to hoard up parallel resources for insulating it against business continuity or other business disasters.

Accumulation of wealth: This is about anticipating how much regular and periodic savings would amount to over a period of time, and how much wealth it creates. Choosing what to invest in is the most important factor in deciding how wealth gets accumulated. Some people or businesses may invest in the markets or on speculative real estate; others may invest on potential high return earners such as intellectual property.

Strategies for tax-planning: Tax becomes a major deduction as one’s income goes up. So, a key element of financial planning is to invest money with the aim of optimizing tax returns. This is possible with some knowledge of tax rates, tax rebates and incentives, and with some professional advice.

Planning for retirement: This is a key element of financial planning for individuals. We all retire at some stage. So, in the prime of one’s life, one need to foresee at what time one is going to retire, how the retired life is going to be spent, what are the possible expenses at that point of time, how much money is going to come during retirement, and so on.

http://www.compliance4all.com/

Cyber crime Trends & Predictions for 2015

Making a prediction of cybercrimes trends for a particular year is a bit like a roll of the dice. These predictions can be absolutely accurate, in the range of anywhere between 0 and 100 percent! If one were to take up a topic like cybercrime trends & predictions for 2015, it is akin to the predictions that exit polls make. Some could be spot on, and some others could miss the bull’s eye by a mile.

Yet, rather than becoming so gloomy and pessimistic about cybercrime trends & predictions for 2015, anyone who wants to go about this exercise could take a look at past trends. Sometimes, past performances and trends could be indicators of the future. Note the cautious use of the word “sometimes” here, rather than an assertive and confident exclusion of this word. Again, it is possible that on other occasions, history may not be a guide in any way at all, as has happened at various times in the past.

An antivirus protection company, ESET, carries out annual surveys and research on topics such as cybercrime trends & predictions for 2015. The findings of this report could perhaps serve as some pointer to our topic of discussion.

In its cybercrime trends & predictions for 2015 research, ESET has summarized the following points:

There will be a high rise in the number of targeted attacks: The most important highlight of the ESET study on cybercrime trends & predictions for 2015 is its emphasis on the increase in the number of targeted attacks. Mass attacks on randomly selected corporate sources are now going to become passé. ESET’s rationale for this part of cybercrime trends & predictions for 2015 is that such personalized, targeted attacks rose by an astonishing 1800 percent 2014 from the previous year. ESET believes that this trend is highly likely to continue. This has coupled with a sharp rise in the number of data breaches, in which the healthcare sector is most vulnerable, taking over two fifths of all the attacks.

The PCI industry is likely to become more vulnerable: Another among the prime cybercrime trends & predictions for 2015 from ESET is the increased vulnerability of data carried by the payment card industry. The possibility of an increase in the hacking of credit card and debit card passwords is another finding of ESET’s cybercrime trends & predictions for 2015. Exposure of millions of cards from Target and Home Depot to malware in 2014 is the basis for this part of cybercrime trends & predictions for 2015.

Growth of IOT is likely to expose it to attacks: The Internet of Things (IOT) is being thought of as the next disruption in technology. While few could doubt this claim; a phenomenon of such proportions is likely to bring challenges that are unique to it in its wake. As humungous volumes of data become available on the www; there is always the increased risk of exposure, too. This is another of the dire cybercrime trends & predictions for 2015.

Online currency payments are likely to come under attack: This is another of the important cybercrime trends & predictions for 2015. ESET estimates that online currency payment options such as Bitcoin are likely to become soft targets of malware and ransomware. A disturbing new trend among cybercrime trends & predictions for 2015 is the evolution of Dogecoin, a digital currency system in which a smart crook doesn’t even need passwords to hack the account; the system affords the opportunity to create new money.

http://www.compliance4all.com/

What is a food safety program?

A food safety program is a must to ensure that consumers get to eat food that is hygienic and nutritive. The main aim of a food safety program should be to see to it that food that is consumed is free of pathogens. This is particularly important today, when food is no more purely localized. Food grown in a part of the world gets processed in different ways and gets eaten in another part of the world, usually many thousand miles away.

To ensure that there is uniform safety and nutrition in this global food chain and that the food is hygienic, regulatory bodies around the world have promulgated a food safety program that consists of safety and hygiene standards. Such a food safety program is collectively called the Hazard Analysis and Critical Control Points (HACCP).

Scientific process

The HACCP is a food safety program that takes a scientific approach to ensuring that the hazards associated with meat production and production of other food materials are eliminated and neutralized by the use of set standards of production and distribution. This food safety program is a comprehensive program that is implemented right across the food chain from start to finish.

As a food safety program, HACCP believes in the old adage that prevention is better than cure. It lays very high emphasis on prevention of food borne pathogens getting into the food chain, rather than taking firefighting measures later, when these steps may not be very effective. The HACCP insists on the application of systematic, scientific and logical standards and principles in meeting its goals of ensuring food hygiene and safety.

As the term suggests, HIPAA is a food safety program that consists of both analysis of hazards present in the food and identification of critical points, controlling which is the key to ensuring the success of this food safety program. It seeks to put in place controls at various critical points of the food chain. Not only should the process in control; there should be documentable proof of it, too.

Three approaches of the food safety program

The HACCP food safety program aims to bring about food safety by controlling and preventing three sources of hazards:

Biological hazards: Aims to control the infusion to bacteria, viruses such as E.coli and many other related ones, and molds;

Chemical hazards: The HACCP food safety program ensures that chemicals such as sanitizers, cleaning agents, antibiotics and others do not cause hazard to food;

Physical hazards: This is to ensure that physical objects such as shards, glass, nails and many other related ones do not cause hazards into the HACCP food safety program.

http://www.compliance4all.com/

SOX Compliance for IT

The Sarbanes–Oxley Act of 2002, more commonly called SOX, is a federal law that the American Congress passed with the intention of bringing in greater probity and accountability into US public accounting and management firms and public company boards. It came into existence in the light of major accounting scandals that rocked the US economy at that time, such as WorldCom and Enron, and its chief purpose was to put regulations in place that assigned responsibilities of a company at the board level. It created a new set of laws on how public corporate entities are to be governed, and are to be in compliance with. It also prescribes penalties and punishments for a company’s board of directors.

SOX compliance requirements for IT

IT is one of the major disciplines the SOX legislation has amended.  First and foremost, SOX compliance for IT starts off from a new plane. It approaches compliance requirements for IT from the standpoint of the need for welding the company’s financial audits with its technological audit. This presents a big shift, because in most instances, financial audits used to focus on the financial aspects of the company, while IT audits used to be concerned with only the technological aspect, with there being almost no conjunction between the two.

Moreover, SOX compliance for IT makes it mandatory for people at the highest levels of the companies’ management boards, such as Board of Directors, CEO’s, CFO’s and Audit Committee to vet and produce the relevant documentation of their companies’ financial records as well as to ensure that there is totally verifiable reliability and security in the IT systems that contain the financial details. This marks a very major shift from the previous legislation in this matter, as SOX compliance for IT brings into its fold senior management into the financial and IT audits of a company, and more importantly, makes them work in tandem.

Other important features of SOX compliance for IT systems

The crux of the prime Information Technology section of SOX is related in Section 404, commonly referred to as “SOX-404”.

Salient features of SOX compliance for IT systems

  1. Section 404 requires controls to be in place. SOX compliance for IT systems seeks to ensure that there are ample controls for preventing fraud, loss or misuse of data relating to the company’s transactions;
  2. SOX compliance for IT systems seeks to also ensure that these controls are effective. To ensure this, SOX compliance for IT systems requires companies to put the kinds of controls in place that ensure that irregularities are quickly detected and facilitate speedy correction;
  3. It allows companies to clearly state exceptions, which must be part of audit trails, so that the right action can be taken to tackle these exceptions;
  4. SOX compliance for IT systems makes IT systems a part of the larger corporate financial and governance controls audit, which companies have to comply with.

http://www.compliance4all.com/