Wednesday , November 25 2020

SOP

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MAINTENANCE OF FINISHED GOODS STORES AIR CONDITIONING SYSTEM MAKE: BLUE

OBJECTIVE            To lay down a procedure for Maintenance of Finished Goods Stores Air Conditioning system SCOPE This SOP is applicable to Finished Goods Stores Air Conditioning System, Model: ACU20B, Capacity: 18 Ton of Refrigeration. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Daily Maintenance Check and ensure that …

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MAINTENANCE OF SAMPLING BOOTH

OBJECTIVE          To lay down a procedure for Maintenance of Sampling booth  SCOPE This SOP is applicable to Sampling booth. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE           . Quarterly Maintenance Check and ensure the free rotation of the blower motor shaft. Check the full …

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MAINTENANCE OF RAW WATER DISTRIBUTION SYSTEM

OBJECTIVE            To lay down a procedure for Maintenance of Raw Water Distribution System                 SCOPE This SOP is applicable for Raw Water Distribution System. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE  Monthly Maintenance Check the motorized valves functioning of auto valves. Check free rotation of auto valve manually. …

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MAINTENANCE OF VENTILATION SYSTEMS (SUPPLY & EXHAUST)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE This SOP is applicable to Ventilation System (Supply & Exhaust). RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if damaged and  clean the …

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10 Easy Skin Secrets Dermatologists Don’t Want You to Know

Good skin is the basis for a beautiful look. Some of the world’s most beautiful people begin with beautiful skin.  While some people are genetically blessed without much effort, some of us need extra effort to achieve that flawless look. Small changes in your daily routine can have a big …

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Securing an orphan drug designation (Published in PharmaTimes magazine – November 2016)

By George Underwood Getting an orphan designation isn’t as simple as just targeting a rare disease. Tim Coté, former director of the FDA’s Office of Orphan Products, tackles the most common mistakes companies make “The three most important things for companies tackling rare diseases to get right are regulatory affairs, regulatory …

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New study finds modified virus could stimulate immune attack on liver cancer cells

A new study conducted by researchers at the University of Leeds, UK, has found that a modified form of Reovirus could be used to launch an immune attack on liver cancer cells. The virus was able to stimulate the immune system to destroy liver cancer cells in mice and can …

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FDA approves implantable device that changes the shape of the cornea to correct near vision

June 29, 2016 — The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of …

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Alembic Pharma gets USFDA nod for hypertension tablets By PTI | Nov 18, 2016, 05.52 PM IST

NEW DELHI: Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for its Telmisartan and Amlodipine tablets used for treatment of hypertension. The company has received approval from the US Food and Drug Administration (USFDA) for Telmisartan and Amlodipine tablets in the strengths of of 40mg/5 mg, …

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Sun Pharma Halol site being inspected by US FDA: Sources By Vikas Dandekar, ET Bureau | Updated: Nov 18, 2016, 09.56 AM IST

MUMBAI – The US FDA has begun its inspection at Sun Pharma  Halol manufacturing facility, considered to be the most crucial for the company, according to three industry sources. Last December, the US drug regulatory agency had issued a warning letter to the same site. The action followed over 20 …

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MAINTENANCE OF DUST COLLECTION SYSTEM WHIRL WIND MAKE

OBJECTIVE                                               To lay down a procedure for Maintenance of Dust Collection system SCOPE This SOP is applicable to all Dust Collection system. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Weekly Maintenance  Check and ensure the belts are not loose or excessive tight. Ensure no air leakage from …

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MAINTENANCE OF CONDENSOR WATER PUMPS/ CHILLED WATER PUMPS, MAKE: BEACON

OBJECTIVE                                    To lay down a procedure for Maintenance of Condenser water Pumps/ Chilled Water Pumps SCOPE  This SOP is applicable to A/C plant Condenser/Chilled Water Pumps. RESPONSIBILITY  Technical Supervisor / Engineer                    ACCOUNTABILITY  Sr.Executive / Manager                                 PROCEDURE Daily Maintenance Clean the motor, pump, pipelines etc. externally with Cora cloth. Check any …

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MAINTENANCE OF BOREWELL PUMP MAKE: KSB, MODEL: UMA-C150

OBJECTIVE            To lay down a procedure for Maintenance of Bore well Pump                   SCOPE This SOP is applicable to bore well Pump, Capacity: 34 m3/HR.         RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Monthly Maintenance Clean the contactors with CTC / CRC. Ensure the pump load should be in …

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DISPOSAL OF DUST COLLECTED FROM DUST COLLECTION SYSTEM

OBJECTIVE            To lay down a procedure for Disposal of Dust collected from Dust Collection System. SCOPE This SOP is applicable to all Dust Collection Systems. RESPONSIBILITY Technical Supervisor / Engineer                    ACCOUNTABILITY Sr.Executive / Manager          PROCEDURE Frequency     Dust is removed system wise, once in a Month. Dust is removed during product …

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MAINTENANCE OF COOLING TOWER

MAINTENANCE OF COOLING TOWER OBJECTIVE                                               To lay down a procedure for Maintenance of Cooling Tower SCOPE This SOP is applicable to Cooling Tower. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Daily Maintenance Check for any vibration and abnormal noise from the Total unit. Check and ensure free …

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MAINTENANCE OF COMPRESSED AIR DISTRIBUTION

OBJECTIVE                                               To lay down a procedure for Maintenance of Compressed Air Distribution SCOPE This SOP is applicable to Compressed Air Distribution. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE  Daily Maintenance Clean the filter bowl externally with dry Cora cloth Ensure no waste material should be lie on …

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MAINTENANCE OF RAW MATERIAL COLD STORAGE, CAPACITY 5TR (TON OF REFRIGERATION)

OBJECTIVE            To lay down a procedure for Maintenance of Raw Material Cold Storage SCOPE This SOP is applicable to Raw Material Cold Storage. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Daily Maintenance Check and ensure the temperature of the cold storage should be with in the limit …

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MAINTENANCE OF CHILLED WATER LINE

OBJECTIVE                                   To lay down a procedure for maintenance of Chilled Water Line SCOPE This SOP is applicable to Chilled Water Line.                        RESPONSIBILITY Technical Supervisor / Engineer                    ACCOUNTABILITY Sr.Executive / Manager                                 PROCEDURE Daily Maintenance Give the chemical dosing of 2902 …

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Process Validation: General Principles and Practices (January 2011)

INTRODUCTION The principles and approaches that all manufacturers can use to validate manufacturing processes. This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonization (ICH) guidance’s for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical …

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Sanitization of Purified Water Generation and Distribution System

Objective:To lay down a procedure for Sanitization of Purified Water Generation and Distribution system. Scope:This Standard Operating Procedure is applicable to the formulation plant. Make/Capacity and EQ. ID. No. are as follows:- Sr. No.                         Make                           Capacity                      EQ. ID. No. 1.0                   …

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