Title: SOP for Cleaning of Equipment in Production Department (EU Focus) II. Purpose: III. Scope: IV. Responsibilities: V. Procedures: Additional EU-specific considerations: VI. Cleaning Solutions and Materials: VII. Cleaning Frequency: VIII. Additional EU Focus: Interstitial Ad
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1.0 OBJECTIVE To lay down the standard cleaning and operation procedure for Rapid mixer granulator 150 L. 2.0 SCOPE This SOP describes the cleaning and operation of Rapid mixer granulator 150 L with co-mill installed in production department at EquipmentMakeModel / CapacityEquipment IDRapid mixer granulator 150 LSSPMSigma Gran / 150 LPRD/E004 3.0 RESPONSIBILITY 3.1 Production Department 3.1.1 Production
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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES) The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is, therefore, needed in the design, maintenance and use of premises and equipment in order to overcome these problems. Wherever required, enclosed dust control manufacturing systems shall
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Preparation of MFR in Pharmaceutical Industry. What Is MFR? A Master Formula is required for each batch and batch size. A “batch” or “lot” as defined. in the WHO GMP guideline (TRS 908 Annex 4) is” “batch (or lot) A defined quantity of starting material, packaging material, or product processed in a single process or series of
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