2020/06/30

What are CGMPs? Why are CGMPs so important?

What are CGMPs? CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards. It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards. Why are CGMPs so important? A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.

2020/06/30

Do You Know That The Invention Of The Capsule Is Actually Because Of This？

Over the years, the growth of the pharmaceutical industry has also driven the development and evolution of capsules as a medicine delivery method. By allowing patients to take medicine orally has made this field of medical treatment much less invasive than giving subjects needles and/or suppositories, thereby making capsules a highly popular option among the general public. Wondering how this vehicle came about in the first place? This article will uncover secret history of capsules, revealing the pioneers behind this important invention in modern medicine, from a primitive empty capsule filling machine to modern capsule filling devices like the ProFiller system.

2020/06/30

Method For Preparing Spongy Graphene By Freeze Dryer

Graphene is a honeycomb two-dimensional lattice structure lamellar nano-material formed by closely mixing carbon atoms in sp2 hybrid mode. Since its discovery in 2004, graphene has attracted the attention of researchers with its excellent physical and chemical properties. It has rapidly become a research hotspot in the fields of physical chemistry, material energy, life sciences and information technology. Graphene's special monoatomic layered structure gives it a very large specific surface area, and sp2 hybridization gives it many wonderful properties and excellent physicochemical properties. In terms of mechanical properties, it has high strength and high modulus; in thermal properties, it has high thermal conductivity; in terms of electrical properties, it has high electrical conductivity. In addition, Graphene has some special properties, such as: Graphene has quantum Hall effect and ferromagnetism at room temperature. Since the discovery of graphene, scientific researchers have been trying to prepare graphene by different methods. At present, according to the principle of preparation, it can be divided into physical methods and chemical methods. The physical method, that is, the method of mechanical peeling, can be further divided into a micro mechanical peeling method and a solvent peeling method. The chemical methods mainly include a graphite oxide reduction method, a thermal decomposition SiC method, and a chemical vapor deposition (CVD) method.

2020/06/30

10 Easy Steps for Cleaning Your Tablet Press

Nothing can slow production down like equipment that malfunctions or stops working altogether. Performing regular, preventative maintenance of equipment is essential and helps keep pharmaceutical tablet presses functioning efficiently and smoothly. Tablet presses that are not well maintained can cause a multitude of problems, creating defective products that are mal-formed, contaminated or contain improper dosages. One of the most important steps to maintaining your tablet press is keeping it clean. It’s also important to have systems in place to validate and document the cleanliness of the equipment.

2020/06/30

The function and significance of capsule filling machine

With the rapid development of pharmaceutical industry, people's demand for capsule filling machine is increasing, and the quality requirements of drug filling are also increasing. At present, the equipment of each industry is developing towards the direction of realizing automation in an all-round way. So let's learn about the next capsule filling machine, and introduce to the pharmaceutical enterprises how to realize the automation of capsule filling, so as to meet the requirements of fast, stable and hygienic requirements of pharmaceutical enterprises.

2020/06/30

Oral Solid Dosage Pharmaceutical Formulation Market Is Anticipated To Collect Of US$ 926.3 Bn By 2027

Apr 30, 2019 (MARKITWIRED via COMTEX) -- VALLEY COTTAGE, N.Y. -Instead of increasing pipeline productivity for biologics and patent cliff challenges, oral solid dosage forms hold substantial opportunity in extending product lifecycle and leveraging growth potential. Manufacturers are employing various life cycle management patent strategies which include obtaining patents on isomers, metabolites, prodrugs, and new drug formulations such as extended, controlled, or rapid release formulations.

2020/06/30

Solid Dosage Manufacturing-Opportunities abound for solid dose CMOs

Solid dosage may not be as sexy as some of the novel drug delivery forms of recent years, but they remain far and away the prevalent dosage form on the market. The contract manufacturing market for them continues to grow, spurred on partly by new, smaller entrants into the marketplace, product line extensions, and large Pharma companies' need to rethink their manufacturing platforms. We spoke with a number of solid dosage CMOs to find how they view the industry, the regulations, the technologies, and their plans for the future.

2020/06/30

Hemp Extraction Turning out to be a Huge Growth Opportunity for Cannabis Companies

It may be the hottest portion of the hottest market in 2019. But such a demand also creates questions about is there enough supply to meet that demand of basic resources especially the extractors; the ones who extract the CBD from its various sources. Some observers even predict that there won't be enough supply to meet the demand for cannabis in oil form. But as one article said: "business is booming for cannabis extraction companies, despite the supply shortages." Some of the bigger well known cannabis companies have built or are building their own extraction facilities to complement their growth operations, but experts say that that infrastructure won't fill the future demand for cannabis oil products. Active Healthcare companies in the markets this week include: Sugarmade, Inc. (OTCQB:SGMD), Hemp Inc. (OTCPK: HEMP), Puration, Inc. (OTCPK: PURA), Terra Tech Corp. (OTCQX: TRTC), Village Farms International, Inc. (NASDAQ: VFF) (TSX: VFF.TO).