cGMP and Regulatory Updates

1.0 PURPOSE : To specify norms for clothing to be used at workplace. Explanation : Appropiate clothing at workplace, footwear and headgear are extremely important from safety point of view. 2.0 GUIDELINES : 2.1 Get dressed for work wearing clothing, headwear and shoes prescribed for the type of your work. 2.2 Wearing of neckties, scarves, ornaments like bangles or loose necklaces, earring etc. may prove hazardous while working on or near moving or unguarded parts of machines and hence should not be worn while at work. 2.3 Never wear loose fitting sleeves when working on moving machinery. 2.4 Laboratory overalls should be worn while working in laboratory to avoid chemical contamination and for the purpose of personal safety. 2.5 Work clothing should be regularly laundered and kept in good repair. 2.6 Appropriate sterile uniforms should be worn while workin...

1.0 PURPOSE Purpose of this SOP to establish and provide procedure for carrying out Pest and Rodent Control Operations. 2.0 SCOPE This procedure is to be followed at Vital Healthcare. This procedure is very essential to maintain the clean and hygienic condition in the factory premises and process areas. This is also to avoid damage to the material in the factory premises. 3.0 RESPONSIBILITY Concerned Operator who has given the work should follow the procedure and concerned supervisor should ensure that procedure is followed correctly. 4.0 MATERIAL AND EQUIPMENTSA Pest and Rodent Control Plan, Rodent Trap, Approved Pesticide and Rodenticide, Spray pump, Safety Goggle, Nose mask etc. 5.0 PROCEDURE 5.1 Rodent Control a) Use only in house approved rodenticide for rodenticide treatment. At present rodenticide containing 0.005 % W/W Bromodiolene and Zinc Phosphide ...

1.0 Company Information 1.1 Human and Financial resources. 1.2 Knowledge of GMP requirements 1.3 Organization a) Structure b) Responsibilities. 1.4 Customer Support a) Installation and service. b) Technical support c) User training. 2.0 Quality System –General. 2.1 Management’s stated policy and commitments. 2.2 Quality group’s responsibility and authority. 2.3 Written Company quality plan. 2.4 Management Review of quality system. 3.0 Quality System –Software Development. 3.1 Development Plan a) Functional Requirements. b) Software design specifications. c) Programming standards and procedures. d) Programming tools...

1.0 Formaldehyde Solution 37% (Formalin) sufficient to vapourise about 35 ml of Formalin for each cubic metre of enclosed space. a) Large stainless steel evaporating pans. b) Thermostatically controlled hot plates. c) Small stainless steel canisters with perforated stainless steel lids. Polyurethane pieces. d) Adhesive tapes e) Goggles f) Aseptic area garments, duly sterilized g) Thermometers h) Petri dishes with nutrient agar media. 2.0 PRECAUTIONS 2.1 Formalin is a strong irritant and is toxic. Inhalation of formaldehyde gas should be avoided since it cause irritation of the respiratory tract. Contact with the skin should also be avoided. 2.2 When Formalin is being handled, protective clothing inclusive of rubber gloves and goggles must be worn. Personnel must leave the area being fumigated as soon as possible after placing the pans of Fornalin on the hot plate...

1.0 OBJECTIVE To provide format and guidelines to participate in the implementation for infestation prevention and treatment of pesticides from areas in which manufacturing and packing are carried out or raw materials, Finished products or Packing components are stored. (Rodents, Insects, Cockroaches, Bed Bugs, Ants, House flies, Bandicoots, Mosquitoes, Flies, Lies, Mites, Picks) 2.0 SCOPE This procedure is design to ensure the exclusion of Rodents and insects from all areas of the plant. 3.0 RESPONSIBILITY Pest control ( India Ltd. ) Jalgaon on yearly basis. 4.0 PROCEDURE I ) DISINFESTATION This treatment aims at controlling all crowling Insects, pests mainly Cockroaches, Bed bugs, Silver fish, Ants, Red & Black ants & Similar other crowling insects in the plant are carriers of pathogens of causing diseases like Gastric Enteritis, Cholera vibris etc. Mode Of Treatment The treatment will comprise of a suitable, residua...

1.0 Purpose: The purpose of this document is to qualify new facility, in order to establish documented evidence that the facility has been designed and installed as per the approved design specifications, made operational, perform as intended and meets the requirements of national and international requirements/ guidelines for c GMP`s, safety and environment. 2.0 Reason for Establishing protocol for qualification of the facility: Facility has been designed and constructed to facilitate manufacturing and packing of tablets, hard gelatin capsule and dry syrups formulations at Bommasandra Industrial area. Hence qualification of the facility is planned. 3.0 PROTOCOL APPROVAL SIGNATURES 4.0 Scope: This protocol is applicable for qualification of the facility of Micro labs limited, Bommasandra, Bangalore . 5.0 Validation team and responsibilities: Engineering Department: Execution, compilation and review of data Quality Assurance : Preparation, review and...