April 2011 : Pharmaguideline

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SOP for Strip Packing Machine

1.0 OBJECTIVE To lay down the procedure for Operation of Strip Packing Machine.
2.0 SCOPE This SOP shall be applicable for the operation of Strip Packing Machine in Packing Area in Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production/ Assigned Designee
5.0 PROCEDURE 5.1 STRIP PACKING MACHINE OPERATION 5…

Limit Test for Iron and Lead

Iron Dissolve the specified quantity of the substance under examination in water, or prepare a solution as directed in the monograph, and transfer to a Nessler cylinder. Add 2 ml of a 20% w/v solution of iron-free citric acid and 0.1 ml of thioglycollic acid, mix, make alkaline with iron-free ammonia solution, dilute to 50 ml with water and allow standing for 5 minutes. Any color produced is not…

Operation and Cleaning of Tray Dryer

Operation 1. Before operating the tray dryer, ensure that it is clean.
2. Ensure that main switch is OFF.
3. Load the material/ accessories to be dried in the tray. Close the door of the tray dryer.
4. Switch on the mains. Set the desired temperature as per BMR.
5. Start the blower and then start the heater.

Cleaning 1. Switch OFF the electrical mains of tray dryer.
2. Remove UNDER USE label and put …

SOP for Stirrer

1.0 OBJECTIVE To lay down the procedure for Operation of Stirrer.
2.0 SCOPE To lay down the procedure for Operation of Stirrer.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Production person shall ensure the cleanliness of the stirrer, its part & area and ‘CLEANED’ label on it…

Pharmaceutical Administration and Regulations in Japan

Pharmaceutical Administration and Regulations in JapanFront cover / Contents
CHAPTER 1. ORGANIZATION AND FUNCTION OF THE MINISTRY OF HEALTH, LABOUR AND WELFARE
CHAPTER 2. PHARMACEUTICAL LAWS AND REGULATIONS
CHAPTER 3. DRUG DEVELOPMENT
CHAPTER 4. POST-MARKETING SURVEILLANCE OF DRUGS
CHAPTER 5. SUPPLY AND DISSEMINATION OF DRUG INFORMATION
CHAPTER 6. HEALTH INSURANCE PROGRAMS AND DRUG PRICING IN JAPAN
In…

SOP for Colloid Mill

1.0 OBJECTIVE To lay down the procedure for Operation of Colloid Mill.
2.0 SCOPE This SOP shall be applicable for the operation of Colloid Mill in Coating area in the Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Production person shall ensure the cleanliness…

Contents Uniformity (Weight or Volume) of Packaged Dosage Forms

The following tests and specifications apply to oral dosage forms and preparations intended for topical use that are packaged in containers in which the labeled net quantity is not more than 100 g or 300 ml or 1000 units, as the case may be. For higher labeled quantities the test and limits given in the standards of Weights and Measures (Packaged commodities) Rules, 1977 may be followed.

Ointment…

WHO News letter

WHO Newsletter on Risk Management Principles used for WHO Inspections of API facilities - Click here to view Newsletter

Operation and Cleaning of Tablet Inspection Machine

1.0 PRE STARTUP 1.1 Visually check the equipment and area for its cleanliness. Ensure that no remnant of previous product / batch is present.
1.2 Check the temperature and relative humidity of the area and record the details in the respective log books.
1.3 If the environmental conditions are not within the limit, do not start the operation and inform to the maintenance department.
1.4 If the condi…

SOP for Volume Delivering Systems (Peristaltic Pump)

1.0 OBJECTIVE To lay down the procedure for Operation of Volume Delivering Systems (Peristaltic Pump).
2.0 SCOPE This SOP shall be applicable to Volume Delivering Systems (Peristaltic Pump) in Coating Area.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 PERISTALTIC PUMP 5.1.1 Check …

SOP for Overprinting of Batch Details on Cartons and Catch Covers

1.0 OBJECTIVE To lay down the procedure for overprinting of batch details on cartons and catch covers.
2.0 SCOPE This SOP shall be applicable for all the batch overprinting operations carried out in Packing Department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Production person…

Operation and Cleaning of Tablet Deduster Machine

PRE-START UP 1. Ensure that no remains of previous product/ batch is present.
2. Visually check the equipment and area for its cleanliness.
3. Affix “CLEANED” label on the equipment.
4. Ensure specified temperature and relative humidity of the area.
5. Ensure that the equipment is getting three phase alternating current supply.
6. Ensure that the de-dusting machine is in working condition.
7. Ensure t…

SOP for Tablet Inspection Machine

1.0 OBJECTIVE To lay down the procedure for Operation of Tablet Inspection Machine.
2.0 SCOPE This SOP shall be applicable for operation of Tablet Inspection Machine in the manufacturing area of the Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Check that the…

Thin-Layer Chromatography (TLC Method and Apparatus)

Thin-layer chromatography is a technique in which a solute undergoes distribution between two phases, a stationary phase acting through adsorption and a mobile phase in the form of a liquid. The adsorbent is a relatively thin, uniform layer of dry finely powdered material applied to a glass, plastic or metal sheet or plate. Glass plates are most commonly used. Separation may also be achieved on t…

SOP for Vacuum Cleaner

1.0 OBJECTIVE To lay down a procedure for operating and cleaning of Vacuum Cleaner.
2.0 SCOPE This SOP shall be applicable for operation and cleaning of Vacuum Cleaner in the production area.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 OPERATING 5.1.1 Connect the top with power s…

Operation and Cleaning of Roll Compector

PRE-STARTUP 1. Check the cleanliness of the room.
2. Check the material lying in the room and ensure that it is of the same batch to proceed.
3. Remove the clean tag of the equipment and tear them off after confirming the details.
4. Put the equipment label on the machine.
5. Check the room temperature and relative humidity and record it in BMR / environment control monitoring card if it is not …

SOP for Deburring & Dedusting Machine

1.0 OBJECTIVE To lay down the procedure for Operation of De-burring & De-dusting Machine.
2.0 SCOPE This SOP shall be applicable for the operation of De-burring & De-dusting Machine in Compression area in the Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE …

SOP for Rapid Mixer Granulator

1.0 OBJECTIVE To lay down the procedure for Operation of Rapid Mixer Granulator.
2.0 SCOPE This SOP shall be applicable for Rapid Mixer Granulator capacity-600 liter in Granulation area in the Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Production person sh…

SOP for Automatic Capsule Filling Line

1.0 OBJECTIVE To lay down the procedure for Operation of Automatic Capsule Filling Line.
2.0 SCOPE This SOP shall be applicable for Automatic Capsule Filling Line in the Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Production person shall ensure the cleanlin…

Procedure for Operation and Cleaning of Rapid Mix Granulator (RMG)

PRE-STARTUP 1. Check the cleanliness of the room.
2. Check the material lying in the room is of the same batch to proceed.
3. Remove the clean status label of the equipment and tear off them after confirming the details.
4. Put the equipment label on the machine.
AT THE TIME OF BATCH CHANGEOVER OF THE SAME PRODUCT 1. Check and ensure the cleanliness of the equipment/ area.
2. Remove the clean equipm…

Principle and Calibration of TOC (Total Organic Carbon) Analyzer

Introduction of organic matter into water systems occurs not only from living organisms and from decaying matter in source water but also from purification and distribution system materials. A relationship may exist between endotoxins, microbial growth, and the development of biofilms on pipeline walls and biofilm growth within pharmaceutical distribution systems. A correlation is believed to exi…

SOP for Compression Machine 27 Stations (Double Rotary Type)

1.0 OBJECTIVE To lay down the procedure for Operation of Compression Machine 27 stations (Double Rotary Type).
2.0 SCOPE This SOP shall be applicable for the operation of Compression Machine 27 stations (Double Rotary Type) in Compression area at Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production/ Ass…

SOP for Compression Machine 20 Station (Single Rotary Type)

1.0 OBJECTIVE To lay down the procedure for Operation of Compression Machine 20 station (Single Rotary Type).
2.0 SCOPE This SOP shall be applicable for the operation of Compression Machine 20 station (Single Rotary Type) in Compression area at Production department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assi…

Drug Information Update- FDA Approves Rituxan to Treat Two Rare Disorders

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, no…

Operation and Cleaning of Octagonal Blender

STARTUP OPERATION 1. Check and ensure the cleanliness of the machine.
2. Bring the material near to the equipment to be blended.
3. Set the timer as per product specification mentioned in BMR. Load the material.
4. Switch ON the main push button and run the machine. Set RPM as per product specification mentioned in BMR.
SHUTDOWN 1. Switch OFF the main power supply.
2. Inform the maintenance peop…

SOP for Conveyor Belt in Packing

1.0 OBJECTIVE To lay down the procedure for operation of the conveyor belt in the packing department.
2.0 SCOPE This SOP shall be applicable for operation of the conveyor belt in the packing department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production/ Assigned Designee
5.0 PROCEDURE 5.1 Affix the status label of Product …

SOP for Paste Kettle

1.0 OBJECTIVE To lay down the procedure for Operation of Paste Kettle.
2.0 SCOPE This SOP shall be applicable for Steam Jacketed Paste Kettle in Granulation area at Production Department.
3.0 RESPONSIBILITY 3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY HOD-Production / Assigned Designee
5.0 PROCEDURE 5.1 Production person shall ensure the cleanliness o…

Testing Procedure (Method of Analysis) for Lactates, Lead Compounds and Magnesium Salts

Lactates To 5 ml of a solution of the substance under examination containing about 5 mg of lactic acid or to 5 ml of the prescribed solution add 1 ml of bromine water and 0.5 ml of 1M sulphuric acid. Heat on a water-bath, stirring occasionally with a glass rod until the color is discharged. Add 4 g of ammonium sulfate, mix and add dropwise, without mixing, 0.2 ml of a 10 percent w/v solution of …

Procedure for Operation and Cleaning of Metal Detector

1.0 PRE STARTUP 1.1 Ensure that no remains of previous product/ batch are present.
1.2 Visually check the equipment and area for its cleanliness.
1.3 Ensure “CLEANED” label on the equipment.
1.4 Ensure specified temperature and relative humidity of the area.
1.5 Ensure that the equipment is getting single phase alternating current supply.
1.6 Ensure that the metal detector is in working condition.
1.7…

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