PHARMA GUIDE

* It is a procedure to ensure that the manufacturing products to a defined set   of quality criteria. * Quality control is that part of GMP concerned with sampling, specification,   testing, documentation and release procedures. * Which ensure that the necessary and relevant tests are performed and the   product is released for use only after ascertaining its quality. * Resources: Adequate facilities              Qualified personnel              Approved written procedures. * Tasks: Sampling       Inspecting               Testing               Releasing or Rejecting               Monitoring * Objects: Starting materials                  Intermediates                  Bulk ...

* Here we are discussing about Role and Responsibilities of QA officers in Pharma industry. * Ensure SOP's are available for all the quality related activities and they are current. * Approving procedures like sop's specifications, the method of analysis, bpcr's, master formula and forms. * Ensure internal audits are carried out as per schedule and necessary corrective actions are taken. * Ensure changes are handled properly and co-ordinate with regulatory affairs dept for speed approvals. * Preparations of master validation plans and review and approval of validation protocols and reports. * Handling of customer complaince. * Ensure maintenance and calibration and validation of equipment/instrument is carried out as per schedule. * Preparation of annual product quality review reports. * Ensure proper archiving and retrieval of documents. * Ensure external audits complaints. * Ensure vendor qualifications. * Ensure that training needs of all departme...

How to apply for DHA? Latest info... -  The pharmacists have to apply online Pharmacist fall in Allied Health category, initially the online application will be reviewed (takes approximately 15 days). -   Create DHA (Sheryan Account), Go to https://eservices.dha.gov.ae/DHAWeb/Default.aspx. Click New User Registration and after filling profile click Create User. There is no Fee for this. -  Login in to your DHA account, click for Individual/Individual Home and then click Health Licensing Services then go to New Professional License. At first they will ask you to fill online Application form, select Allied Health in “I am looking for field” and complete remaining profile. Upload required scanned documents to your DHA Account: The documents to be upload are 1- PASSPORT 2- RECENT PICTURE 3- DEGREE (Pharm D/ Pharm B) 4- TRANSCRIPT RELATED TO THE DEGREE 5- GOOD STANDING CERTIFICATE     *(This certificate u can get from pharmacy council of your home country...

·          Here we are discussing about important, role and posts of Regulatory Affairs. ·          Regulatory Affairs used to protect public health from the medicines. ·          IMPORTANTS OF REGULATORY AFFAIRS: ·          Identification of various regulatory options for drug development. ·          Optimising the products. ·          Speeding it means Time to Market strategic thinking. ·          Involvement in critical business functions. ·          Engagement in manufacturing site optimisation activities. ·          Regulatory expertise throughout the product lifecycle. ·      ...

Here we are discussing about role of Kuwait pharmacist in hospitals. Initially we have to send request for medicine to the central medical store. These request are three types those are 1. normal request                                      2. special request                                      3. urgent request. After that we receive the stock and it will arrange alphabetically. Then we should register the stock as per our indent. And handling of prescription for the out patients. handling of discharge the patients. Preparation of in-patients prescriptions. Supply of ward stock and other pharmacy requests. We have to do daily stock check in the morning. At the same time we have to check expiry medicines properly. Follow 365 circular drugs process. Maintain unit dose manage...

We are discussing about Batch Production Control Record check list. The BPCR review should cover and typically requires the reviewer to initial each section that has been reviewed. A specific check list should be prepared for each type of finished drug product because the manufacture of tablets, capsules and oral liquids vary by process and parameters. The important check points are mentioned here, those are * Check for total number of pages. * Check for batch numbers on all pages. * Check for issued signature. * Check whether all the columns are filled properly. * Check for over writings. * Check for QC reference numbers for all the raw materials. * Check the dispencing labels ate attached and filled completely. * Check all the parameters like temperature, pressure are recorded as per BPCR. * Check all the in process samples sent to QC as per BPCR. * Check the Yield column filled. * Is there any Deviation related to this batch, wether the deviation is clos...

We are discussing about ICH Guidelines part-2. The International Conference on Hormonisation of techinical requirments for registration of pharmaceuticals for human use. Since its inception in 1990, ICH has gradually evolved to respond to the incresingly global face of drug development. The ICH guidelines are explained in 4 different topics, those are 1.Quality topics           2.Safety topics           3.Efficacy topics           4.Multi disciplinary topics. The work carried out by ICH under the Efficacy heading is concerned with design, conduct, safety and reporting of clinical trials. The clinical trials are two types, those are pre-clinical trials and clinical trails. The pre-clinical trials are carried throughout the animals, after its succeed it will entered in human body and it is commonly called as clinical trials. It is also covers novel types of medicines derived from biotechnological...