– Incoming drums/ containers/ boxes/ bags are cleaned – All materials according to Process Order (PO) are available – No breakage/ leakage in the container – No materials except relevant to this batch are present – Correct materials of sufficient amount with approved label – ...

Monophasic liquid dosage forms: It contains only one phase. Syrups: A liquid preparation typically containing a high concentration of sugar (or sugar substitute),usually the concentration of sugar is 66% (w/w), a flavoring agent, and active drug ingredients.Syrups are a popular delivery vehicle for ...

These products have semisolid consistency and applied to skin or mucous membranes for therapeutic orprotective action or cosmetic purpose. The following preparations belong to semisolid dosage products:creams, ointments, gel and pastes having viscous consistency. Definitions: Ointment: An ointment is ...

Gel Mass Compounding: The process of blending and heating granulated gelatin andother ingredients in warm water in a gelatin melting tank. With appropriate heat, mixing andvacuum, the ingredients form thick syrup called a “gel mass” for use in encapsulation. Colormay be added during the melting ...

Design qualification is defined as a verification process of design to meet specific requirements related to quality of pharmaceuticals and manufacturing practices. However, design qualification procedures in pharmaceuticals are one of the reasons why some products do not make it onto drugstore shelves. It ...

Performance Qualification (PQ) performed after successful completion of the Installation and Operational Qualifications execution, for those critical systems or processes requiring PQ that should be validated to provide assurance of process repeatability. One of the purposes of PQ is to test the ability ...

Operational Qualification (OQ) has to be performed after satisfactory completion of the system/equipment Installation Qualification execution. The OQ describes the operational tests, measurements, and control tolerances of key parameters that are critical for the proper operation of the system. Test ...

The data collected during the Installation Qualification can be packaged and summarized either individually or as part of an IQ/OQ/PQ package for presentation, review, and approval. The Installation Qualification Protocol provides a systematic method to check the system/equipment static attributes ...

All extraneous materials & equipments/accessories except relevant to this batch are removed Waste Bin is cleaned All the equipment inside the room including SS table utensils and scoops arecleaned All materials/ equipments are labeled properly All protective clothing of processing personnel i.e. ...

All sterilisation processes should be validated. Particular attention should be given when the adopted sterilisation method is not described in the current edition of the European Pharmacopoeia, or when it is used for a product which is not a simple aqueous or oily solution. Where possible, heat sterilisation ...