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Showing posts with the label Pharma Updates

GOOD DOCUMENTATION PRACTICES

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document. THE IMPORTANCE OF DOCUMENTATION: As per GMP "If it is not written down, then it did not happen". The document provides information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be. BASIC REQUIREMENTS OF GDP: 1. Always record the entries at the time of activity simultaneously. 2. Always record date with signature in GMP records. 3. Always use an indelible ballpoint pen to record data in GMP records. 4. Always enter the data directly in the  GMP records in the English language. 5. Never use a pencil or erasable or water-soluble ink pen to complete the GMP records. 6. Never use white ink or correction fluid to correct the entry in GMP records 7. Never sign for someone else on any document. Only...

TYPES OF TABLET TOOLING

Definition of Tablets Tablets can be defined as Solid Pharmaceutical Dosage form containing drug substances with or without suitable  diluent  and prepare either by compression or  moulding  methods. Tablet Tooling For this purpose different types of punches are used: Flat- faced bevel- edged. Shallow concave (Round/ Capsule shaped) Standard concave (Round/ Capsule shaped) Deep concave (Round/ Capsule shaped) Extra deep. Modified ball The basic mechanical unit in all tablet-compression equipment includes a lower punch which fits into a die from the bottom and an upper punch, having a head of the same shape and dimensions, which enters the die cavity from the top after tablet material fills the die cavity. PROCUREMENT OF  TOOLING While ordering any punch set ( From Approved Supplier only ), following things should be covered: Drawing for upper/lower punch / die, by the manufacturer as per the specifications given or as per samp...

Walk in for macleods pharma panchkula on 30 July 2017

FLUIDIZED BED DRYER (FBD) AND TYPES OF BAGS USED

Fluidized bed dryers, their construction, working, FBD finger bags, finger bag MOC and their features and application in pharmaceutical manufacturing. Drying in pharmaceutical manufacturing   is the removal of water and other liquid solvents from the granules or other materials by heat and a current of air. Fluidized bed dryer is used to dry the granules in pharmaceuticals using FBD finger bags. Principle of Fluidized Bed Dryer (FBD): 1. In fluidized bed dryer hot air is passed at high pressure through a perforated bottom of the container containing granules to be dried. 2. The granules are lifted from the bottom and suspended in the stream of air this condition is called fluidized state. 3. The hot air is surrounding every granule and dries them completely. Therefore, the granules dry equally. Construction: The dryer is generally made up of stainless steel. A removable bowl is attached at the base of the dryer that is used for loading and unloading o...