cGMP and Regulatory Updates

1.OBJECTIVE: To lay down a Standard operating procedure for Rubber Bung Washing Machine. 2.SCOPE: This procedure provides a standard method to operate the Rubber Bung Washing Machine. 3.RESPONSIBILITY: •Machine Operator. •Senior Chemist. •Head - Production. 4.PROCEDURE: 4.1.Check and ensure that the Rubber Bung washing machine is free from dust & it is cleaned as per SOP No:P/P/015. 4.2.Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/053 4.3.Fill the vessel with solution of 0.1% Tween 80 and DM water. 4.4.Transfer the Rubber Bungs to be washed into the vessel. Supply the steam into it at 116°C/10 lbs for 35 mins. 4.5.After 35 mins cut the steam supply & give compressed air to remove the foam which is formed because of the Tween 80 solution. Drain the washed water. 4.6.Add sufficient quantities of DM water which is filtered through 5µ filter. Apply the filtered steam and compressed air at a pressure of 4 Kgs/cm2 for half an hour. 4.7.Dra...

1.OBJECTIVE: To lay down a standard operating procedure for Automatic Ampoule Filling & Sealing Machine 2.SCOPE: This procedure provides a standard method to operate and handle the Automatic Ampoule Filling & Sealing Machine. 3. RESPONSIBILITY: Machine Operator. Senior Chemist. Head - Production. 4.PROCEDURE: 4.1.Check and make sure that Automatic Ampoule Filling and Sealing machine has been cleaned as per SOP No: P/P/010 4.2.Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/044 4.3.Make sure that the filling area has been cleaned properly. 4.4.Switch on the Laminar flow and make sure that, it has been wiped with 70% IPA. 4.5.Feed the Ampoules to an inclined charging hopper from Sterilized S.S boxes. 4.6.The Ampoules are passed continuously through rotating feeding wheel, which in turn transfers the Ampoules positively to Ampoule conveyor with the help of charging hopper. 4.7.The Ampoule conveyor carries the Ampoules vertically at an angl...

1.OBJECTIVE: To lay down a standard procedure for Optical Checking of filled vials and ampoules. 2.SCOPE: This procedure provides a standard method of optical checking of filled Vials and Ampoules for the presence of any foreign particles. 3.RESPONSIBILITY: Supervisor - Visual checking. Senior Chemist. Head - Production. 4.PROCEDURE: 4.1.Check and make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/049 4.2.Transfer the filled ampoules/vials into the plastic crates with proper labelling and given for individual checking. 4.3.Keep the ampoules/vials in an inverted position to check for sealing, black particles under white board and Glass pieces, white pieces & fiber particles under black board by shaking the Ampoules/Vials for two to three times. 4.4.If necessary clean the ampoules/vials with a wet cloth. 4.5.Segregate and put the good and rejected Ampoules/Vials in the respective crates with lids. 4.6.Put green label for good Ampoules/Vials. 4....

1.OBJECTIVE: To lay down a standard procedure for Bubble Point Test. 2.SCOPE: This procedure provides a standard guidelines to validate the membrane by performing the Bubble Point test. 3.RESPONSIBILITY: Senior Chemist. Head - Production. 4.PROCEDURE: 4.1.Check and make sure that the area is clean & free from the previous product and any other materials related to previous products. 4.2.Fill the distilled water in the bubble point apparatus which has been autoclaved. 4.3.Connect the Nitrogen tube with the Bubble point apparatus and outlet of the Bubble point apparatus to the membrane holder. 4.4.Pass the Nitrogen in the Bubble point apparatus to pump the water to membrane holder. The filtered water gets collected in the collection tank. 4.5.After completion of filtration, dip the Nitrogen tube in collection tank and observe for the bubbles. 4.6.If any air bubble was found at less than the pressure level mentioned below. It is concluded that the membrane fails in bubble point test a...

1.OBJECTIVE: To lay down a Standard Operating Procedure for laminar flow. 2.SCOPE: This procedure helps to provide standard guidelines to operate and handle the laminar flow. 3. RESPONSIBILITY: Operator. Senior Chemist. Head - Production. 4.PROCEDURE: 4.1 Check and make sure that the area is clean & free from the previous product and any other materials related to previous products. a.Ensure that the instrument is clean, free from dust and placed in such a position, that any air dust while opening the air-lock door do not affect the positive pressure of the instrument. b.Switch on the mains. c.There are three switches and a pressure barometer side panel of the instrument Switch (1) AIR-FLOW Switch (2) LIGHT Press ’switch (1)’ to start the AIR-FLOW through the HEPA Filters d.The AIR-FLOW should be kept ‘ON’ for about 5 minutes before carrying out any work under laminar flow. e.Check the level of red-oil indicator should be at 10 to15 mm mark of water column, when AIR-FLOW is ‘ON’...

Corrective action and related subsequent audits should be completed within a time period agreed between the manufacturer and the auditing organisation. The auditing organisation may request from the manufacturer follow up reports on the implementation and results of corrective action. Such reports should be reviewed by the auditing organisation and the review results communicated to the manufacturer

The audit process applies to initial, surveillance and special audits. 1 Preparation 1.1 Notification Where permitted by the regulatory requirements, the manufacturer should be notified in advance that an audit is to be conducted. 1.2 Preview of quality system description As a basis for planning the audit, the lead auditor may carry out a preliminary review of the manufacturer's documented methods, such as the quality manual, for meeting the regulatory requirements. This preview should be considered to be part of the execution of the audit. If this review reveals that the system described by the manufacturer is not adequate to meet the regulatory requirements, further resources should not be expended on the audit until such concerns are resolved to the satisfaction of the auditing organisation. 1.3 Site visit audit plan There shall be a site visit audit plan. If permitted by the regulatory requirements, it should be communicated to and agreed with the manufacturer,...