cGMP and Regulatory Updates

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.

1.     Objective: To lay down a procedure to govern the Sanitation by cleaning and disinfecting 2.     Scope: This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory by cleaning and disinfecting. 3.     Responsibility: 01        Head – QA 02        Head – Administration. 4.     Procedure: 4.1    TABLET AND CAPSULE MANUFACTURING AREA AND STORES. 4.1.1     Any spillage of material must be cleaned up as it occurs.   Powders must not be removed   by sweeping but by suction using a vacuum cleaner followed by wet mopping.   4.1.2   The tracking of powder from one area to another, particularly in the corridors, caused by the operator’s footwear can be minimized by using mats against which the footwear should be brushed.   The mats should be washed and dried everyday. 4...

1.     Objective: To lay down a procedure to govern the Sanitation using cleaning equipments. 2.     Scope: This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory using different source of cleaning equipments. 3.     Responsibility: 01        Head – QA 02        Head – Administration. 4.     Procedure: 4.1       Floor Mops: Mops may be made of sponge and should preferably be of the ‘squeeze’ type.   Cotton mops may also be used provided they do not shed linters.   It is difficult to maintain cloth mops; they should be cleaned in soap water after every use, rinsed free from disinfectant or cleaning solutions.   It would be preferable to have the mop handles in metal or plastic rather than in wood. 4.2       Cloths and Sponges: These are useful on...

1.     Objective: To lay down a procedure to govern the Sanitation of the Pharmaceutical Factory. 2.     Scope: This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory using cleaning agents and disinfectant. 3.     Responsibility: 01        Head – QA 02        Head – Administration. 4.     Procedure: 4.1    DEFINITION: 4.1.1       Cleaning Agent are materials, which help to remove extraneous material from surfaces and objects. 4.1.2       Disinfectants are potent substances, which destroy pathogenic micro-oraganisms but not necessarily resistant spores and are usually applied on inanimate objects. 4.1.3       Antiseptics are reasonably non-toxic substances and may be applied to live tissue for killing micro-organisms or to pr...