cGMP and Regulatory Updates

1.  Objective: To provide a standard cleaning procedure of  mass mixer  and its accessories. 2.  Scope: 2.1       This procedure covers dismantling and cleaning of mass mixer  and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours 3.   Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A. Manager 4.   Procedure: 4.1       Switch off the main and close the material discharge hole . 4.2       Open the lid of themass mixer. Dismantle the propeller blade . 4.3       Wash the dismantled accessories with 0.5% (v/v) Teepol solution, 0.1 % Sodium Lauryl Sulphate by using nylon brush and finally rinse with DM water. 4.4       Fill raw water upto ¼ of the MM and wash with nylon brushes to remove powder of previous product...

1.     Objective: To provide standard cleaning procedure of  Fluidized bed drier and its accessories. 2.     Scope: 2.1       This procedure covers dismantling and cleaning of Fluidized bed drier and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A. Manager. 4.   Procedure: 4.1       Switch off the main supply. 4.2       Dismantle the product chamber, Retard chamber, prefilter and finger bag strap. 4.3       Wash the fixed chamber & dismantled accessories with 0.5% (v/v) Teepol solution and product chamber should be washed with 0.1% Sodium Lauryl Sulphate by using nylon brush. Finally rinse with DM water. 4.4       Wipe whol...

1.     Objective: To provide standard cleaning procedure of Dry Syrup Filling & Sealing Machine & its accessories. 2.     Scope: 2.1       This procedure covers dismantling cleaning and assembling of Dry Syrup Filling & Sealing Machine and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A.Manager. 4.     Procedure: 4.1       Wash all parts of the Dry Syrup Filling & Sealing machine with 0.5%v/v Teepol solution and rinse with DM water. 4.2       After that clean  the machine with dry cloth. 4.3       Collect the washed water and send it to Quality Assurance to check the presence of any residual moiety. 4.4   ...

1.     Objective: To provide standard cleaning procedure of De Foilling Machine & its accessories. 2.     Scope: 2.1       This procedure covers dismantling cleaning and assembling of De Foilling Machine and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A.Manager. 4.     Procedure: 4.1       Remove all the previous products ( tablets,capsules,empty strips) from the De Foilling machine. 4.2       Clean the machine and it parts by clean musclin cloth. 4.3       Then clean the machine by IPA. 4.4       Then dry it properly and then switch on the De Foilling machine. 4.5       After that start...

1. OBJECTIVE: To provide standard cleaning procedure of De Duster & its accessories. 2. SCOPE: 2.1 This procedure covers dismantling cleaning and assembling of De Duster and its accessories. 2.2 Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3. RESPONSIBILITY:  Operator.  Chemist.  Production Manager.  Q.A.Manager. 4. PROCEDURE: The vibratory tablet de-duster is primarily used to de-dust the core tablets, to exclude any loose powder adhering to the surface, otherwise the coated tablets produced are with uneven coating whereby they do not pass through the feed chute on strip sealing machine. Improper cleaning of this de-duster may also contribute addition of particles of the tablets already dedusted on this equipment. Therefore, it is necessary to clean this equipment as per standard operating procedure given below 4.1 As soon as dedusting operation of a particular batch of tablets is over, dismantle the entire sifting chambe...

1.     Objective: To provide standard cleaning procedure of Compression Machine & its accessories. 2.     Scope: 2.1       This procedure covers dismantling cleaning and assembling of Compression Machine & its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A.Manager. 4.     Procedure: 4.1       Dismantle the hopper, feed frame, upper & lower punches and dies. 4.2       Wash the hopper, feed frame & body cover with raw water followed by 0.5%v/v Teepol solution and finally rinse with DM water. 4.3       Wipe all the parts with wet cloth and then with dry cloth. 4.4       Clean the turret, weight adjustment screw, l...

1.     Objective: To provide standard cleaning procedure of Collidal Mill & its accessories. 2.     Scope: 2.1       This procedure covers dismantling cleaning and assembling of Collidal Mill and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A.Manager. 4.     Procedure: 4.1       Switch off the mains. 4.2       Dismantle the hopper, hopper blade and SS hose. 4.3       Transfer all dismantled accessories into the steam kettle. Fill the steam kettle with cold water and heat it by means of steam. 4.4       Wash the accessories with 0.5%v/v Teepol solution. Now add preservatives into it and assemble the washed accessories. 4.5 ...

1.     Objective: To provide a standard cleaning procedure of   AF 40 Capsule filling machine and its accessories. 2.     Scope: 2.1       This procedure covers dismantling, cleaning and assembling of AF 40 capsule filling machine and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯     Q.A. Manager. 4.     Procedure: 4.1       Switch off the mains and close the air valve. Dismantle the hopper, augers, rotating table top, needle plates. 4.2       Wash the hopper with raw water followed by 0.1% sodium lauryl sulphate. 4.3       Wash the auger, rotating table top, needle plates with 0.5%v/v Teepol solution. 4.4       Rinse w...

1.     Objective: To provide a standard cleaning procedure of   Blister packing machine and its accessories. 2.     Scope: 2.1       This procedure covers dismantling, cleaning of Blister packing machine and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ?   Operator. ?   Chemist. ?     Production Manager. ?   Q.A. Manager. 4.     Procedure: 4.1       Switch off the mains, close the air valve. 4.2       Dismantle the hopper, feeding channel, guide track, vibrator bowls, sealing & forming heater, sealing and forming roller, cutting tools main gear. Dismantle the printing gear, printing stereo’s/embossing letters from the cutting tools or BCP (Batch Code Printing) unit. 4.3       Wipe the printing...

1.     Objective: To provide standard cleaning procedure of Balance Used in Capsule Filling. 2.     Scope: 2.1       This procedure covers dismantling cleaning and assembling of Balance Used in Capsule Filling and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A. Manager. 4.     Procedure: 4.1       Remove all the previous products from the base of the balance. 4.2       Clean the balance and its   parts by clean musclin cloth. 4.3       Then clean the balance by IPA. 4.4       Then dry it properly and then switch on the balance. 4.5       After that start   weighing the product.