What are good documentation practices & how can they best be implemented? Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from “good distribution practice” also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards …
Read More »Drug Master Files (DMFs) and it submission
Drug Master Files (DMFs) and it submission Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those …
Read More »Hydroxychloroquine and Antimalarial Drugs (united healthcare)
Hydroxychloroquine and Antimalarial Drugs (united healthcare) These are antimalarial drugs found to induce remission in upto 50% patients of Rheumatoid Arthritis (RA), but take 3–6 months. Their advantage is relatively low toxicity, but efficacy is also low; bony erosions are not prevented. Their mechanism of action is not known, however, …
Read More »Characterization of Fine Particle in Formulation of drugs
Characterization of Fine Particle in Formulation of drugs Parameters those are measured: (i) Particle size and size-distribution (ii) Shape of the particle (iii) Surface morphology of the particles (iii) Zeta potential Instrumental Methods of Particle Size Characterization: (i) Light Microscope: • First a standard graticule (BS 3625) is standardized with …
Read More »PROCESSING OF PARENTERAL PREPARATION
PROCESSING OF PARENTERAL PREPARATION The following steps are involved in the processing of parenteral preparation: 1. Cleaning of containers, closures, and equipment. 2. Collection of materials. 3. Preparation of parenteral products. 4. Filtration. 5. Fill the preparation in the final container. 6. Sealing the container. 7. Sterilization 8. Evaluation of …
Read More »Formulation of Suspensions
Formulation of Suspensions Biphasic liquids such as suspensions and emulsions are unique dosage forms because many of their properties are due to the presence of a boundary region between two phases. In suspensions, a liquid and an insoluble solid meet to form an interface. In the case of emulsions, two …
Read More »Determination of equilibrium solubility of a drug
Determination of equilibrium solubility of a drug Determination of equilibrium solubility of a drug: The drug is dispersed in a solvent. The suspension is agitated at a steady temperature. Samples of the suspension are withdrawn as a function of time, clarified by centrifugation,and assayed to establish a plateau concentration. Solvents …
Read More »QC SOPs List
QC SOPs List SNo. SOPs Title 1.0 SOP on entry & exit procedure in Quality Control Department 2.0 SOP on sampling of raw material. 3.0 SOP on intermediate and finished product analysis and approval 4.0 SOP on analysis of sample by contract laboratory 5.0 SOP on sampling procedure of packaging …
Read More »Quality Assurances SOPs List
Quality Assurances SOPs List SNo. SOP Title 01 SOP on validation master plan 02 SOP on Function of quality assurance department 03 SOP on periodic physical observation of control sample 04 SOP on job responsibility of personnel working in quality assurance. 05 SOP on in-process sampling and analysis of oral …
Read More »PROBLEMS AND REMEDIES FOR TABLET COATING
PROBLEMS AND REMEDIES FOR TABLET COATING Blistering It is local detachment of film from the substrate forming blister. Reason: Entrapment of gases in or underneath the film due to overheating either during spraying or at the end of the coating run. Cause and Remedy of Blistering: Cause: Effect of temperature …
Read More »VALIDATION AND QUALIFICATION OF WATER PURIFICATION,STORAGE,AND DISTRIBUTION SYSTEMS AS PER USP
Purified Water Establishing the Quality of pharmaceutical water purification,storage,and distribution systems requires an appropriate period of monitoring and observation. However, it is more difficult to meet established microbiological quality criteria consistently. A typical monitoring and observation program involves intensive daily sampling and testing of major process points for at least …
Read More »VITAMINS AND MINERALS CHART
VITAMINS AND MINERALS CHART Different types of vitamins and minerals enable healthy body function, such as cell and tissue repair, production of cells, and healthy brain function. Your body doesn’t produce these vitamins and minerals on its own, and while you can get most of these from a supplement, your …
Read More »Design Qualification of Gelatin Storage Vessel
Design Qualification of Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the Gelatin Storage Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …
Read More »Lubricants and Glidants used in Tablet Formulations
Tablets Lubricants Lubricants and Glidants used in Tablet Formulations are: • Magnesium stearate • Stearic acid • Sodium stearyl fumarate • Hydrogenated vegetable oil • PEG 4000, 6000 • Hexagonal boron nitride • DL-Leucine • Sodium lauryl sulfate • Gliceryl behenate • Sodium benzoate • Colloidal silicone dioxide • Talc …
Read More »Pharmaguidances Whats App Groups
Pharmaguidances Whats App Groups Pharmaguidances Pharma Post and Jabs Pharma Vacancy Pharma Post and Jabs 2 Pharmaguideline Pharmaguideline 2 MFR of SALBUTAMOL SULPHATE TABLET
Read More »Preformulation stability studies
Stability Analysis Preformulation stability studies are the first quantitative assessment of chemical stability of a new drug. This may involve 1. Stability study in toxicology formulation 2. Stability study in solution state 3. Stability study in solid state. Stability Study in Toxicology Formulation: A new drug is administered to animals …
Read More »Powder Particle Size Determination Methods for tablets
Particle Size Determination Methods: 1. Sieving 2. Microscopy 3. Sedimentation rate method 4. Light energy diffraction 5. Laser holography 6. Cascade impaction 1. Sieving method: • Range: 50 – 150 μm • Simple, inexpensive • If powder is not dry, the apertures get clogged. 2. Microscopy: • Range: 0.2 – …
Read More »Powder flow properties in Pharmaceuticals
Powder flow properties in Pharmaceuticals Apparent bulk density (g/cm3): Bulk drug powder is sieved through 40 mesh screen. Weight is taken and poured into a graduated cylinder via a large funnel. The volume is called bulk volume. Apparent bulk density = Weight of the powder/Bulk volume Tapped density (g/cm3): Bulk …
Read More »TABLET TOOLING
TABLET TOOLING Basics of Tablet Tooling Tablet compression machines are made keeping in view the type of dies and punches will be used on them. The dies and punches and their setup on compression machine is called tooling, it is classified as B and D mainly. The B tooling dies …
Read More »Preformulation for Tablets, Capsules, Liquid Orals
Preformulation for Tablets, Capsules, Liquid Orals Before developing a formulation like tablets, capsules, liquid orals we study the suitability of new drug or drug and excipients for the chosen formulation which is called preformulation. Preformulation Definition Preformulation may be defined as a stage of the research and development process where …
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