Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.
SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that…
Added by Adam Fleaming on March 22, 2017 at 6:04am — No Comments
Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…
Added by Adam Fleaming on March 16, 2017 at 6:00am — No Comments
Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.
Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.
Lyophilization is considered complex
Parenteral products such as anti-infective drugs,…
Added by Adam Fleaming on March 15, 2017 at 6:18am — No Comments
A financial organization, or an organization involved in any business for that matter, faces the prospect of receiving duplicate, fraudulent or late payments. These are the typical payment issues an organization is likely to face at some point of time in its business.
Payment issues are something almost no organization is likely to be free from. Duplicate invoice payments, just one of the payment issues an organization is likely to face, account for losses of…
Added by Adam Fleaming on March 13, 2017 at 6:02am — No Comments
That the inputted data should be “normally distributed” is a requirement of the calculations used in many statistical tests and methods. Typically, the methods used for Student’s t-Tests, ANOVA tables, F-tests, Normal Tolerance limits, and Process Capability Indices include such calculations.
A core criterion for ensuring the correct results is the one that the raw data used in such calculations be “normally distributed”. It is in view of this fact that the…
Added by Adam Fleaming on March 10, 2017 at 5:39am — No Comments
Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.
Added by Adam Fleaming on March 8, 2017 at 5:12am — No Comments
Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.
The company’s financial statement is intended to provide insights into the…
Added by Adam Fleaming on March 3, 2017 at 5:34am — No Comments
Humans can be calibrated, although most people like to think otherwise. The commonly used standard, Attribute Agreement Analysis, or what is called AAA, is a handy tool in helping to do this. At its barest, Attribute Agreement Analysis is a method in which the level of agreement or conformance between the appraisal made by the appraiser(s) and the standard is assessed. Then, the elements used for the appraisal that have the highest levels of disagreement with the standard are…Continue
Added by Adam Fleaming on February 15, 2017 at 5:54am — No Comments
Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.
The parameters used for quantification of Product Reliability are:
o MTBF or Mean Time Between Failures for products that can be repaired and…Continue
Added by Adam Fleaming on February 13, 2017 at 5:40am — No Comments
After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.
The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…Continue
Added by Adam Fleaming on February 10, 2017 at 6:08am — No Comments
Any company or individual that is required to submit IRS Form 1099 can avail a facility the Internal Revenue Service (IRS) has: the Taxpayer Identification Number (TIN) matching. This matching or likeness is among an assortment of e-services that gives what are called “authorized payers” the opportunity to match and state their own 1099 payee information with the pertinent records from the IRS. The TIN matching is a pre-filing facility, since it is done before an entity files information…Continue
Added by Adam Fleaming on February 8, 2017 at 5:58am — No Comments
The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…Continue
Added by Adam Fleaming on February 6, 2017 at 6:19am — No Comments
Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.…Continue
Added by Adam Fleaming on January 20, 2017 at 5:19am — No Comments
Alternatives to AQL sampling plans do exist, but companies need to be aware of them and explore them. Acceptance Quality Limit, or AQL, is applied as a benchmark in most manufacturing organizations to inspect the quality of products they purchase. It is only when the product meets AQL that the receipt is acknowledged and the payment made.
So, what is AQL?
What is AQL? In simple terms, AQL, which expands to Acceptance Quality Limit, is what…
Added by Adam Fleaming on January 19, 2017 at 5:06am — No Comments
FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does…
Added by Adam Fleaming on January 18, 2017 at 5:02am — No Comments
Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.
Post market surveillance is, in simple terms, the monitoring of the performance and…
Added by Adam Fleaming on January 17, 2017 at 6:56am — No Comments
Financial institutions have long been the most important source of payments for their customers. Of late, though, with an increase in competition and the advent of new non-bank entries into the marketplace, financial institutions have come under a lot more strain than they used to be.
Financial institutions need to reinvent themselves in a number of ways. They need to adapt novel strategies to…Continue
Added by Adam Fleaming on November 25, 2016 at 5:03am — No Comments
Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.
Added by Adam Fleaming on November 22, 2016 at 4:50am — No Comments
Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers.…
Added by Adam Fleaming on November 17, 2016 at 4:43am — No Comments
For those in the field of exploration, there is a need to zero in on an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology should help explorers concentrate their exploration efforts over new areas keeping their budget in control, armed even with limited or nonexistent geological information.…
Added by Adam Fleaming on November 16, 2016 at 4:47am — No Comments