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Compliance4all's Blog (94)

Clarifying the misconceptions about DMFs and Quality Agreements

A Drug Master File (DMF) is a file that lists the materials and processes that have gone into a drug. This submission is made by manufacturers of drugs to the FDA, and has to contain everything that goes into the drug, and has to include not only the materials and the processes; but also confidential information pertaining to the facilities in which the drugs are manufactured. All the inputs that have gone into not just the manufacturing, but also the packaging and storing…

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Added by Compliance4all on May 29, 2017 at 6:13am — No Comments

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.

The purpose of this equipment validation program is to ensure these…

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Added by Compliance4all on May 26, 2017 at 6:21am — No Comments

Why IEC 60825 certification cannot be substituted for 21CFR1040

With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with…

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Added by Compliance4all on May 24, 2017 at 6:31am — No Comments

Webinar Calendar of Upcoming Courses - May to Jun 2017

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Below is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

the most erudite experts on regulatory compliance being available at a click

in the comfort of your preferred location; regulatory compliance could not

get any simpler and effective!

Compliance4All’s experts help you unravel all the knowledge you need…

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Added by Compliance4all on May 22, 2017 at 7:53am — No Comments

Meeting labeling requirements of various drug products

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…

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Added by Compliance4all on May 19, 2017 at 6:17am — No Comments

Regulations governing how combination products are regulated

The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.

21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one…

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Added by Compliance4all on May 17, 2017 at 6:40am — No Comments

EPA’s new Revised Section 608 Refrigerant Management Regulations

In late 2016, the US Environmental Protection Agency (EPA) revised Section 608, which deals with refrigerant management regulations. A number of requirements under this section are set to change. They concern the handling requirements that are applicable to ozone depleting refrigerants, and fortify the existing regulations by…

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Added by Compliance4all on May 16, 2017 at 6:33am — No Comments

Use OneNote to manage your meetings

Microsoft OneNote is a program that works as a digital notebook. It saves users the trouble of having to scramble for a piece of paper whenever they feel like scribbling some information or idea down. Moreover, it saves the user the trouble of having to preserve a piece of paper on which the info is jotted down.

Microsoft OneNote helps users to type, write or draw on the digital notebook while continuing to have the same feel as a regular paper and pen. It is…

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Added by Compliance4all on May 15, 2017 at 6:08am — No Comments

Transiting from paper records to electronic for pharmaceutical companies while being compliant

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper…

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Added by Compliance4all on May 12, 2017 at 6:06am — No Comments

How does the FDA scrutinize Promotion and Advertising Practices?

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should…

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Added by Compliance4all on May 11, 2017 at 6:23am — No Comments

How to implement technology transfer in pharmaceuticals

Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.

Technology transfer is carried out in a number of…

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Added by Compliance4all on May 10, 2017 at 6:41am — No Comments

Understanding cash management in ERP systems and setting up and reconciling bank statements

Cash management is a major component in ERP systems such as Oracle. It is a module that offers information about the most critical component of the business, namely cash flow. Cash management processes and analyzes all of the business’ cash and bank transactions from a number of sources such as:…

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Added by Compliance4all on May 9, 2017 at 6:19am — No Comments

All about human error and ways of reducing it

There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.…

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Added by Compliance4all on May 8, 2017 at 7:48am — No Comments

Understanding the FDA’s thinking behind 21 CFR Part 11 inspections

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in…

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Added by Compliance4all on May 5, 2017 at 6:45am — No Comments

Learn how to future-proof VLOOKUP by using Excel’s Table feature versus referencing static ranges

Professionals in a wide number of industries and businesses find the VLOOKUP function in Excel very useful. Why this is so is that it helps in locating an exact value. Using VLOOKUP, an MS Excel user can find a specific piece of information in the spreadsheet. This is very useful when there are very many values in a grid. In other words, the VLOOKUP…

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Added by Compliance4all on May 4, 2017 at 6:14am — No Comments

Proper handling of Out of Specification (OOS) result is the hallmark of a robust investigation

The whole exercise of drug making is incomplete and unthinkable without laboratory testing. There is no better indicator of success on the part of the drug manufacturer than this activity. This is absolutely essential as a means for confirming that all the ingredients that make a laboratory product, such as the raw materials used in it, the in-process materials as well as the finished materials that go into it, and containers as well, all kowtow to the set, required…

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Added by Compliance4all on May 3, 2017 at 6:23am — No Comments

The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.

An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in…

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Added by Compliance4all on April 27, 2017 at 6:29am — No Comments

Ensuring compliance with drug advertising promotional claims requirements

Advertising is a highly challenging and creative field. However, when making claims about the efficacy and effectiveness of products, especially drug products, advertising professionals need to comply with strict compliance guidelines which set out the limits of claims. The US government lays considerable stress on the veracity aspects of the advertising claims.

An ad for a drug product must state not just the benefits of a product, but also its side effects, risk…

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Added by Compliance4all on April 25, 2017 at 6:22am — No Comments

Understanding the ways of conducting shrink investigations

Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.

Controlling losses is as important…

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Added by Compliance4all on April 21, 2017 at 6:03am — No Comments

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major…

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Added by Compliance4all on April 19, 2017 at 6:44am — No Comments

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