Recall is an action taken to withdraw/remove the drugs from distribution or useincluding corrective action for which deficiencies are reported in quality, efficacy or safety.The defective products related to quality includes Not of Standard Quality, Adulterated orSpurious drugs. Safety and efficacy related recalls include serious adverse reactions anddeath. Recalls also include drugs prohibited under the … Read more
-If sample angle is less than the threshold angle it indicates purity of the peak . -Sample contrast 53 degree, 10 degree and 0.5 degree.
Epoxy flooring is a good choice for pharmaceutical companies because it is durable, easy to maintain, and resistant to chemicals and abrasions. Epoxy flooring is made from a combination of resins and hardeners that chemically react to form a rigid plastic-like material. Pharmaceutical industries are involved in the production of different types of the drug … Read more
Eye drops and other ophthalmic preparations are used by millions of individuals all over the world; in order to keep them safe and guarantee effectiveness, maintaining sterility is vital to proper ophthalmic manufacturing. According to the American Society of Health-System Pharmacists (ASHP) Pharmacy-Prepared Ophthalmic Products guidelines, the following should be considered when preparing eye drops … Read more
Equipment in the pharmaceutical industry should be designed to ensure the expected performance and efficiency. In general, GMP-compliant equipment design must meet the following requirements: Not negatively affect product quality, Easy to clean, Comply with applicable technical regulations, and Suitable for its purpose. The design of equipment should be based on the requirements of the … Read more
Distribution and storage are essential activity in the integrated supply-chain management of pharmaceutical products. Various individuals and entities are generally responsible for the handling, storage and distribution of such products. So it is important to have adequate controls over the entire chain of distribution. To maintain the original quality of pharmaceutical products, every party involved … Read more
Strategy in Pharmaceutical Industry ? Predicting the Future: The pharma industry is rife with uncertainties. Strategic planning helps companies anticipate market shifts and adjust their course accordingly. Optimizing Resources: With limited resources, companies need to prioritize projects that align with their long-term vision and offer the best ROI. There are only five business strategies: cost, … Read more
Cp and Cpk are used for Process Capability. Generally, you use this when a process is under statistical control. This often happens with a mature process that has been around for a while. Process capability uses the process sigma value determined from either the Moving Range, Range, or Sigma control charts. Pp and PPk are … Read more
OBJECTIVE: SCOPE: RESPONSIBILITY: Department Head – Engineering personnel Quality Assurance personnel – ACCOUNTABILITY : Head Quality Control Head Manufacturing – Head Engineering Head Quality Assurance – Precautions during the Qualification activity : Qualification/Verification : Test Stage Qualification/Verification frequency Air Flow Volume and Air Changes At the start of the Qualification Once in 6 months ± … Read more
Tunnel Qualification The sterilization process in a chamber or a hot air tunnel is critical, and regular validation is required. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the dry heat sterilization process has been consistently effective. To qualify such devices, various pharmacopoeias require depyrogenation devices to … Read more