SOP For cleaning & numbering procedure for containers and SS accessories.

Production

OBJECTIVE: The purpose of this SOP is to provide a procedure for the cleaning & numbering procedure for containers and SS accessories. SCOPE: This SOP is applicable to cleaning & numbering procedure for container and SS accessories at manufacturing facility of XXX.    RESPONSIBILITY: Authorized designee of Production shall be responsible for cleaning & numbering procedure …

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SOP for Handling of Tool-Kit

Production

OBJECTIVE: The purpose of this SOP is to provide a procedure for handling of tool-kit. SCOPE: This SOP is applicable to specifies handling of tool-kit at manufacturing facility of XXX RESPONSIBILITY: Authorized designee of Production/Packaging Staff shall be responsible for handling of tool-kit. Head of Production/Packaging responsible for effective implementation of SOP. PROCEDURE: Precaution:   Ensure …

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SOP For Operation of Oscillating Granulator

Production

The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for operation of Oscillating Granulator. SCOPE: This SOP is applicable for the operation of Oscillating Granulator at manufacturing facility. RESPONSIBILITY: 3.1                 Officer/ Executive shall be responsible for operation of Oscillating Granulator Head of production department shall be responsible for effective implementation …

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SOP of Operation and Calibration of Moisture Balance

Production

The purpose of this standard Operating Procedure (SOP) is to lay down a procedure for operation of moisture balance. SCOPE: This procedure is applicable for moisture balance in manufacturing department of Production area at manufacturing facility. Make: Contech  (Modal:CBB-50,Capacity : 50 gm) RESPONSIBILITY: 3.1                 Officer/ Executive shall be responsible for operation of moisture balance. 3.2                 …

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Supporting Clean Areas & Clean Areas Separation in Aseptic Product Manufacturing – USFDA

Aseptic Processing Guidelines

Supporting Clean Areas Supporting clean areas can have various classifications and functions.  Many support areas function as zones in which nonsterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred.  These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological …

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Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA

Aseptic Processing Guidelines

Sterile Product Building, Facility and  Clean Area Classification Guideline By USFDA has clearly mentioned what conditions to be followed to maintain the Sterile Conditions in Sterile Product Manufacturing site. 21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings …

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TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.)

Microbiology

TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.) INTRODUCTION The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used …

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SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

Quality Control

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of Ultrasonic Water Bath. PROCEDURE: PRELIMINARY CHECK: Fill the Water bath with water up to height of minimum 7cm from bottom of tank. Whenever the Ultrasonic Water Bath is required with specific temperature then heater to …

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Sterile Drug Products Produced by Aseptic Processing – USFDA Guideline for Buildings & Facilities

USFDA Guidelines

21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.”21 CFR 211.42(c) states, in part, that “Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined …

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EU Guidelines For Computerized System Part- 2

Quality Assurance

Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment. 4.2 Validation documentation should include change control records (if applicable) and reports on any deviations observed during the validation …

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