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Manufacturing, Packaging & Detailing Market Research Reports & Industry Analysis

Both prescription and over-the-counter (OTC) drugs must be manufactured in accordance with standards established by the Food and Drug Administration (FDA). The agency inspects manufacturing facilities before a drug application can be approved. Any manufacturing deficiencies found would need to be corrected before approval.

Current Good Manufacturing Practices (cGMPs) refers to the regulations enforced by the FDA. The 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.

  • Use of RFID in serialized unique packaging numbering to authenticate and check for recall/expiry status.
  • Use of X-ray and metal detection systems to detect glass, stone, bone, rubber and other contaminants
  • Use of checkweighers and sorters
  • Use of baggers capable of handling, opening and sealing bags manufactured from specialist sterile films and papers.
  • Use of quality control labeling systems

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. This is important because a consumer cannot detect through smell, touch, or sight if a drug product is safe or if it will work.

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Manufacturing, Packaging & Detailing Industry Research & Market Reports

  • Pakistan Pharmaceuticals & Healthcare Q4 2018

    ... especially in light of the uncertainpolicy directions. In addition, the Pakistan-Tehreek-e-Insaf (PTI) political party is expected to upscale health coverage, increase thenumber of emergency units and generally implement programmes to improve health outcomes. Furthermore, the ... Read More

  • Binge Eating Disorder - Pipeline Review, H2 2018

    ... Disorder (Central Nervous System) pipeline landscape. Binge eating disorder is a serious condition characterized by uncontrollable eating and resulting weight gain. The causes of binge-eating disorder are unknown. But family history, biological factors, long-term dieting ... Read More

  • Myanmar Pharmaceuticals & Healthcare Q4 2018

    ... underdeveloped state of the public health sector will shape commercialopportunities for private healthcare providers. Despite this, the upcoming rollout of universal healthcare coverage will improve long-term opportunities for investment in Myanmar’s pharmaceutical and healthcare sectors. Read More

  • Gabon Pharmaceuticals & Healthcare Q4 2018

    ... by factors including modest but growingpopulation numbers, high prevalence of infectious diseases and the growing burden of civilisation diseases. However, given thetight funding environment, most of the commercial opportunities remain limited to the generics sector. Read More

  • United States Pharmaceuticals & Healthcare Q4 2018

    ... on the US pharmaceutical market. Most changesare temporary and pharmaceutical companies are adept at side-stepping market challenges. Potential changes to the rebatesystem in the US could have more far-reaching implications, especially for supply chain intermediaries. Read More

  • Portugal Pharmaceuticals & Healthcare Q4 2018

    ... increasingly important role in the healthcaresystem. Despite rising public health spending, the public hospital sector will continue to face challenges after several years ofdeterioration and management concerns. Although commercial opportunities for drugmakers will significantly improve ... Read More

  • Armenia Pharmaceuticals & Healthcare Q4 2018

    ... the previous administration's courseand, as such, publicly funded access to healthcare services will remain lacking. Longer-term prospects remain dependent on thewider economic situation, especially as private out-of-pocket spending remains the dominant source of healthcare funding. Read More

  • Qatar Pharmaceuticals & Healthcare Q4 2018

    ... and infrastructure continues to expand to meet therising demand for healthcare. Meanwhile, we expect pharmaceutical and healthcare spending to benefit from improving businessand consumer sentiment on the back of rising oil prices. That said, the ... Read More

  • Nigeria Pharmaceuticals & Healthcare Q4 2018

    ... opportunities are supported by robust fundamentals such as a large market size and expandingpopulation. The majority of multinational drugmakers will continue to opt for an indirect presence as the business climate remainsdecidedly difficult in Nigeria. Read More

  • Georgia Pharmaceuticals & Healthcare Q4 2018

    ... interest in the market from the point of view of innovativepharmaceutical companies. Georgia's commercial potential remains limited by negative demographic factors, though someservices, such as cosmetic and plastic surgery, seem to be experiencing a boost ... Read More

  • Turkey Pharmaceuticals & Healthcare Q4 2018

    ... support market growth, driven by the Health TransformationPlan. However, we highlight that increasing macro risks, emphasised by the lira sell-off in August 2018, will increasingly placedownside risks to this expansionary fiscal outlook, leading to growth ... Read More

  • Netherlands Pharmaceuticals & Healthcare Q4 2018

    ... The government and insurers will continue to contain risinghealthcare cost through various cost-cutting measures and pro-generic dug policies. Nevertheless, the country’s strong researchand development infrastructure and aging population make it an attractive destination for innovative ... Read More

  • Cambodia Pharmaceuticals & Healthcare Q4 2018

    ... diseases will underpin rising demand for medical treatment. Meanwhile,the expansion of universal healthcare will boost the utilisation of medical services, enabling greater proportions of populations toaccess treatment. While this will create improved commercial opportunities for ... Read More

  • Belarus Pharmaceuticals & Healthcare Q4 2018

    ... on the use of generic products, andthe encouragement of domestic industry expansion, which discourages use of novel products. The placement of high-valuepatented medicines on the market is disadvantaged by corruption, elevated political risks, limited private ... Read More

  • Botswana Pharmaceuticals & Healthcare Q4 2018

    ... healthcare. Medicine sales will be limited by weakregulatory framework, a small pensionable population and a highly ruralised community. Despite a potential for growth in theunderdeveloped sector, multinational drugmakers will favour larger markets in the region ... Read More

  • Global Sexually Transmitted Diseases Partnering 2012-2018

    ... companies.• Trends in partnering deals • Top deals by value • Deals listed by company A-Z, industry sector, stage of development, technology typeThe report provides understanding and access to the partnering deals and agreements entered ... Read More

  • Global Contraception Partnering 2012-2018

    ... deals • Top deals by value • Deals listed by company A-Z, industry sector, stage of development, technology typeThe report provides understanding and access to the partnering deals and agreements entered into by the world’s ... Read More

  • Global Genitourinary Partnering 2012-2018: Deal trends, players and financials

    ... in Genitourinary partnering deals Financial deal terms for headline, upfront and royalty by stage of development Genitourinary partnering agreement structure Genitourinary partnering contract documents Top Genitourinary deals by value Most active Genitourinary dealmakers Most of ... Read More

  • Global Orphan Diseases Partnering 2012-2018: Deal trends, players and financials

    ... since 2012. Trends in Orphan Diseases partnering deals Financial deal terms for headline, upfront and royalty by stage of development Orphan Diseases partnering agreement structure Orphan Diseases partnering contract documents Top Orphan Diseases deals by ... Read More

  • Analyzing the Global Market for Active Pharmaceutical Ingredients 2018

    ... the market, nevertheless, the market has bounced back with strong growth since then. However, the industry is today facing a record number of blockbuster drugs going off patent. This is having a major impact on ... Read More

  • Global Big Pharma Partnering Terms and Agreements 2012-2018: Deal trends, players and financials

    ... companies enter Big Pharma partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes. This report provides details of the latest Big Pharma agreements announced in the ... Read More

  • Global Bacterial Partnering 2012-2018: Deal trends, players and financials

    ... in Bacterial partnering deals Financial deal terms for headline, upfront and royalty by stage of development Bacterial partnering agreement structure Bacterial partnering contract documents Top Bacterial deals by value Most active Bacterial dealmakers Most of ... Read More

  • Global Respiratory Syncytial Virus Partnering 2012-2018

    ... companies.• Trends in partnering deals • Top deals by value • Deals listed by company A-Z, industry sector, stage of development, technology typeThe report provides understanding and access to the partnering deals and agreements entered ... Read More

  • Global Common Cold Partnering 2012-2018

    ... in partnering deals • Top deals by value • Deals listed by company A-Z, industry sector, stage of development, technology typeThe report provides understanding and access to the partnering deals and agreements entered into by ... Read More

  • Pharmaceutical and Biotechnology Construction Sector Report - UK 2018-2022

    ... UK 2018-2022 ' focuses on the market size, value and activity in the Pharmaceutical, Medical Technology, Medical and Industrial Biotechnology sectors in the UK, the key players and geographical areas of manufacturing and R&D concentration. Read More

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