MedSpace

PURPOSE:  To provide a system for establishment of the holding period for the bulk product during manufacturing process under the relevant storage condition. SCOPE:  This procedure is applicable for the hold time study of bulk product manufactured at X-Pharma.         REFERENCES: In-house          RESPONSIBILITIES:               Quality Assurance: To ensure the implementation of SOP .              Production:   Ø   To coordinate with the hold time study per procedure.   Ø   To maintain the record.            Quality Control: Analyses the sample as per procedure.             DISTRIBUTION:   Ø   Quality Assurance   Ø   Production   Ø   Quality Control        DEFINITIONS AND ABBREVIATIONS:         HEALTH, SAFETY, AND ENVIRONMENT:       PROCEDURE:   Ø   The frequency for the bulk holding time study will be 4 weeks and 6 weeks or on the basis of fixed period.   Ø   The bulk holding time studies will be carried out on scale up /

Hey viewer, If you like this post, kindly comment below the post and do share your response. Thanks for reading.

What is the System for Australian Recall Actions (SARA) ? It is an online, searchable Database that you can use to find information about recall actions for therapeutic goods that have been co-ordinated by the TGA. It includes  recalls ,  recalls for product correction  and  hazard alerts  for a range of therapeutic goods including: Prescription medicines Over the counter medicines Complementary medicines Medical devices including in-vitro diagnostic medical devices (IVDs) Biologicals Why are recall actions undertaken? A recall action is undertaken in response to a problem that has been identified with a therapeutic good. Recall actions may also be undertaken for precautionary reasons. By notifying the public about recall actions and in some cases removing potentially deficient products from the market, the exposure of the public to potentially unsafe therapeutic products is reduced. A recall action is a market action taken to resolve a problem with a

The new  pharmacovigilance  legislation, which came into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It had significant implications for applicants and holders of EU marketing  authorizations, as well as for patients, healthcare professionals and regulators. Background to the  pharmacovigilance  legislation: The development of the  pharmacovigilance  legislation was based on the observation that  adverse drug reactions  (ADRs), ‘noxious and unintended’ responses to a medicine, caused around 197,000 deaths per year in the EU. Because of this, in 2005 the European Commission began a review of the European system of safety monitoring including sponsoring an independent study, as well as extensive public consultation through 2006 and 2007. This process resulted in the adoption of  new Directive and Regulation  by the European Parliament and Council of Ministers in December 2010, bringing about signifi

Women in the UK will be able to self-administer an injectable contraceptive for the first time after the medicines regulator approved new labelling for Sayana Press.  to see more Cut of nursing cost Sample:1 Sample:2

দীর্ঘ কয়েক মাসের দর-কষাকষির পর বিশ্ব বাণিজ্য সংস্থায় (ডব্লিউটিও) মেধাস্বত্ব আইনের বাধ্যবাধকতা থেকে আরও ১৭ বছরের ছাড় পাচ্ছে স্বল্পোন্নত দেশগুলোর (এলডিসি) ওষুধশিল্প। এর ফলে বাংলাদেশসহ স্বল্পোন্নত দেশগুলোর জেনেরিক ওষুধ উৎপাদনের জন্য মেধাস্বত্ব আইন প্রযোজ্য হবে না। আগামী সপ্তাহে জেনেভায় মেধাস্বত্ব অধিকারের বাণিজ্য-বিষয়ক চুক্তি বা ট্রিপস কাউন্সিলের সভায় এই ছাড়ের বিষয়ে আনুষ্ঠানিক ঘোষণা দেওয়ার কথা রয়েছে। জেনেভায় বাংলাদেশের স্থায়ী প্রতিনিধি শামীম আহসান শনিবার প্রথম আলোকে এ তথ্য জানান। তিনি বলেন, গত বৃহস্পতিবার সন্ধ্যায় বিশ্ব বাণিজ্য সংস্থায় এলডিসির সমন্বয়ক বাংলাদেশের সঙ্গে যুক্তরাষ্ট্রের দীর্ঘ আলোচনা শেষে এলডিসিকে এ বাধ্যবাধকতা থেকে অব্যাহতি দেওয়ার বিষয়ে ঐকমত্য হয়েছে। জেনেভায় বাংলাদেশের স্থায়ী মিশন থেকে পাঠানো এক বিজ্ঞপ্তিতে শনিবার বলা হয়েছে, মেধাস্বত্ব অধিকারের বাণিজ্য-বিষয়ক চুক্তির (ট্রিপস) আওতায় পেটেন্ট আইনের বাধ্যবাধকতা থেকে স্বল্পোন্নত দেশগুলোকে অব্যাহতি দেওয়ার মেয়াদ ২০১৬ সাল থেকে আরও ১৭ বছর বাড়ানোর সিদ্ধান্ত হয়েছে। ঢাকার একটি কূটনৈতিক সূত্র জানিয়েছে, বিশ্ব বাণি

No one walks down the aisle on their wedding day with visions of their future divorce dancing in their heads, but statistics show separation is inevitable for some couples. This is especially true for the ones who get hitched young. Before age 32, each additional year you wait to get married can reduce the risk of divorce by 11 percent, according to data from Nicholas H. Wolfinger, a professor of Family and Consumer Studies and adjunct professor of Sociology at the University of Utah. But what about people who do actually have to go through the whole young-and-divorced thing? Here, five women share what they learned in the process and the advice they'd give to anyone in their shoes. "To the girls out there going through the same thing, I'm not saying that taking a trip is the answer, but find something that fills you with excitement and accomplishment.  Something that will make you say, ‘I did it, and that's why I'm awesome.’ Most of all, love yours