Isnare Free Articles
Authors Contents [Add OpenSearch]

Richard Soltero: Isnare.com Free Articles Author

Richard Soltero

1 - 16 of 0 article(s) found

Date Joined: February 10, 2013

Country: United States

 
 
Advertise at iSnare.com - Guaranteed Top Exposure starting at $12 only!

An article by an Isnare.com Premium Author An Overview of Manufacturing Software For GMP Production

Author: Richard Soltero

Category: Computers and Technology

The transition to electronic manufacturing is now at full tilt due to the technological systems developments that has occurred over the last 25 years, and now, electronic manufacturing is the industry standard for manufacturing companies who must comply with current Good Manufacturing Practices (cGMP) There are countless benefits to making the transition to electronic manufacturing, however, small to mid-sized manufacturing companies and the contact manufacturing organizations which support them continue to resist making the switch Companies are hesitant to make the change due to the cost and amount of time required to switch from paper to electronic manufacturing systems...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – What is GMP in China?

Author: Richard Soltero

Category: Medical Business

Can Chinese pharmaceutical manufacturers live up to international GMP requirements The Chinese government in the early 2011 announced the final draft of GMP (Good Manufacturing Practice) The pharmaceutical industry is apprehensive whether GMP compliance in China can be successfully implemented...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – the 4 Steps For Changing From Paper to Electronic Batch Records

Author: Richard Soltero

Category: Medical Business

The vast majority of FDA regulated companies still use manual systems for GMP manufacturing While many are convinced their life could be simpler with an electronic manufacturing system, they are reluctant to make a change We will talk about the guiding principles and a step wise process that can help bring about a change to a more efficient process for manufacturing using a manufacturing execution system with electronic batch records...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – What Is GMP In Russia?

Author: Richard Soltero

Category: Medical Business

There are multiple challenges to meeting GMP in Russia including bureaucracy and past pharmaceutical practices The state of GMP compliance in Russia is not yet up to Western standards Currently only 50 of Russia’s 528 drug factories meet international GMP standards...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – What Is GMP In India?

Author: Richard Soltero

Category: Medical Business

GMP compliance in India is a work in progress Pharmaceutical manufacturing has become a significant industry in India It has been estimated that has the third largest pharmaceutical industry by volume...

An article by an Isnare.com Premium Author Instant GMP Compliance Series - Dietary Supplements Testing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

FDA regulations mandate that manufacturing firms test dietary ingredients and establish identity specifications prior to using the ingredients in manufacturing Regulations also state that manufacturers must conduct a minimum of one test or examination to confirm the identity of components classified as a dietary ingredient In most cases, certificate of analysis documents of dietary ingredients that are supplied by third party suppliers are not sufficient enough to prove identity for manufacturing firms...

An article by an Isnare.com Premium Author Instant GMP Compliance Series - How To Make Vitamin Supplements That Meet GMP Regulations

Author: Richard Soltero

Category: Wellness, Fitness and Diet

In the US, the FDA regulate the manufacturing of vitamin supplements and require they are manufactured following Good Manufacturing Practices (GMPs) The Food and Drug Administration passed these regulations in 2007 and they took effect over the next three years Now vitamin manufacturers who are found to be out of GMP compliance may face seizure or other regulatory actions...

An article by an Isnare.com Premium Author Instant GMP Compliance Series - What is Quality by Design?

Author: Richard Soltero

Category: Computers and Technology

The pharmaceutical manufacturing business is one of the most controlled and regulated industries in the world Regulatory methods such as GMP (Good Manufacturing Practices), PAT(Process Analytical Technology), and the newest, QbD (Quality by Design) all ensure that pharmaceutical products are safe and of high quality for consumers to purchase and use QbD is the scientific background behind improving manufacturing process and thus the products through extensive and meticulous planning...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – Better Compliance Through Effective Master Manufacturing Records

Author: Richard Soltero

Category: Wellness, Fitness and Diet

A review of warning letters revealed that there is a wide-spread lack of Master Manufacturing Record (MMR) documentation at Dietary Supplement producers The FDA has found problems in many master records where there have been failures to establish specifications for the identity of the components especially dietary ingredients, for purity and prevention of adulteration, strength or assay value, composition, and for limits on contaminants They has also firms with adequately established MMRs who failed to meet specifications, to qualify their suppliers, and who failed to record completion of steps and resulting outcomes...

An article by an Isnare.com Premium Author Instant GMP Compliance Series - Improving Batch Production Records For Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

There are a number of examples where the FDA found batch record violations that ultimately resulted in them issuing a Warning Letter Milk Specialties Global, a dietary supplement company, received a FDA warning letter after an inspection of their plant in Wautoma, Wisconsin The company was cited by the FDA for keeping incomplete batch records of the supplements and for failure to document their decision making process when production steps deviated from requirements...

An article by an Isnare.com Premium Author Instant GMP Compliance Series - Avoiding Equipment Issues in GMP Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Medical Business

The equipment used in GMP production of dietary supplements must comply with the FDA requirements as outlined in their DSHEA Act This article summarizes these requirements Putting it in a nutshell, the FDA (the U...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – Packaging And Labeling In Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

GMP Problems The FDA did not regulate packaging or labeling of dietary supplements until 2007, when the Dietary Supplements Health and Education Act (DSHEA) came into law Then in 2010, the Act was applied to all packagers and distributors of dietary supplements, meaning they too had to come under GMP compliance Since FDA inspectors began investigating dietary supplement companies in 2010, one quarter of inspected manufacturers have received FDA Warning Letters...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – Equipment In Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

GMP Problems: Dietary Supplements must be manufactured within cGMP regulations which are listed in the Dietary Supplements Health and Education Act that became law in 2007 The FDA has inspected many dietary supplement manufactures and distributors which have resulted in half of the companies receiving citations for failure to be within GMP requirements in 2010 Half of the companies that were cited also received Warning Letters from the FDA threating to halt all processes until compliance issues were resolved...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – Facility Design In Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

GMP Problems: Since 2007, dietary supplement manufacturers have to be within GMP regulations under the Dietary Supplement Health and Education Act The Act spells out regulations relating to manufacturing facility designs, locations, and operational processes “Grandfathered in” manufacturer facilities are not exempt from compliance within the Act, and thus must adjust their facilities to become compliant...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – Facility Areas In Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

GMP Problems: Dietary Supplements Health and Education Act (DSHEA) came into law in 2007 and was completely implemented in 2010 DSHEA mandates all dietary supplement manufactures be in compliance with Good Manufacturing Practices (cGMPs) located in the regulation act Regulations include layouts, locations, and operations of the manufacturing facility...

An article by an Isnare.com Premium Author Instant GMP Compliance Series – Complaints and Recalls in Dietary Supplement Manufacturing

Author: Richard Soltero

Category: Wellness, Fitness and Diet

GMP Problems: The ability to find key issues in product complaints can be a tool to improving overall quality The manufacturer must first assume responsibility for the product’s quality, and then ensure that the costumer used the product as its intended use All complaints should be handled swiftly and in a positive manner...