Paste Kettle A paste Kettle (starch paste kettle) including a tilting paste kettle is designed for paste preparation. Starch Paste Kettle confirms cGMP norms and comprises a jacketed hemispherical bowl with all necessary steam accessories. The design principle of this kettle is the jacket for passing steam in order to melt down the product to…
Disposal of in-process & rejected products OBJECTIVE: To lay down a procedure to describe the steps to be followed for disposal of in-process samples & rejected products during manufacturing. SCOPE: This SOP covers the disposal of in-process samples / rejected products, manufactured.. RESPONSIBILITY: IPQA and Production personnel shall be responsible to follow the procedure mentioned…
JOB RESPONSIBILITIES OBJECTIVE To lay down the Procedure for preparation of Job Responsibilities. PROCEDURE To maintain a satisfactory system of Quality Assurance and manufacturing of drug products, as per cGMP requirements. Total operation is divided into various functions, called Departments. The following are the departments : Warehouse Production Engineering & Utility Quality Control Quality Assurance…
Corrective and preventive action OBJECTIVE : To lay down a standard procedure for corrective and preventive action(s) system related to product quality/system attributes. PROCEDURE : Definitions: Corrective action: Action is taken to eliminate the root cause of an existing non – conformity, defect, or other undesirable situation in order to prevent a recurrence. Preventive Action:…
Good Documentation Practices OBJECTIVE: To lay down a procedure to describe the steps to be followed for good documentation practices; and ensure that each personnel receives clear and detailed description of the relevant job assignment to minimize the risk of misinterpretation and error. PROCEDURE : Principle: Good Documentation constitutes an essential part of the Quality…
Product Recall OBJECTIVE: To lay down the Procedure for handling Product Recall. PROCEDURE: Recall: Recall means a firm’s removal of products from the market that considers being adverse reaction or in the case of patient safety, a violation of the law. Withdrawal: Withdrawal means a firm’s withdrawal, removal, or correction of a distributed product from…
Release of finished products OBJECTIVE: To lay down the procedure for the release of finished products. PROCEDURE : Ensure that the Batch Manufacturing Record has been reviewed and audited by Production in all aspects. The reconciliation of the materials and product yield is carried out at the respective stages of the operation. Ensure that the…
Batch Release At Various Manufacturing Product OBJECTIVE: To lay down procedure for stage wise release of the batch. PROCEDURE: In Process Tablets Release for Compression Receive QC release for Blend in writing. Check that the line clearance has been carried out by Production & verified by QA. Check that the BMR is duly filled &…
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Product Quality Review OBJECTIVE: To lay down the Procedure for preparation of Product Quality Review. PROCEDURE : Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and…
Deviation Control OBJECTIVE: To lay down the procedure to describe the steps to be followed in case of planned/unplanned deviation from the standardized activity, or standard procedure. PROCEDURE : Deviations are of two types: Planned & Unplanned. Planned Deviation: Any Deviation in the procedure, process, equipment, or standard batch size which is planned, documented, assessed…
OBJECTIVE: To lay down the procedure for Change Control System. PROCEDURE: If anybody wants to make a change in the existing system and feels that the change will be fruitful in terms of productivity, and quality; he/she should discuss it with his / her department head. If the department head feels that it is required,…
OBJECTIVE: To lay down a procedure for handling Product Complaints. PROCEDURE : Any department receiving the complaint must forward it to the Head of Quality Assurance. Complaints received by any other way of communication (Handwritten, email, telephonic) should also be attended to. Any acknowledgment, regarding the quality of the product, received from the health authority…
Training of Employees OBJECTIVE: To provide a procedure for adequate training to all employees, & workmen as appropriate to their job responsibilities, specific to the area of working & related to GMP. PROCEDURE: The training shall normally include the following, but not be limited to. Safety, personal hygiene & health aspects. GMP & GLP Functional…
General Instruction for Packing of Water for Injection BATCH PACKING ACTIVITIES Line Clearance for Dispensing of secondary packing material Dispensing of secondary packing material Line Clearance for secondary Packing Area Label Specimen Checks Visual Inspection & labeling In- process Check during visual inspection In- process Check during labeling Final packing In- process Check during packing…
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DOCUMENTATION STANDARDS The cliché of the three Ds — documents, documents, and more documents — is apt for FDA PAI inspections. Historically, regulatory agencies have relied heavily on cross-checking documents to ascertain the state of compliance with the cGMP regulations. The documents of critical importance are the batch records that contain detailed information about the…
FACTORY ACCEPTANCE TEST OF INDUCTION SEALING MACHINE WITH 5 FEET CONVEYOR BELT Contents Objective Scope Responsibility Verification of Technical Specification Verification of Material of Construction Verification of Instruments Verification of Operation Verification of InterLock Machine Trail Sheet Suggestions/ Modifications FAT Closed Out OBJECTIVE: To verify that the machine at the Manufacturer’s site is ready as…
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INSTALLATION QUALIFICATION OF DRY SYRUP FILLING MACHINE Contents Pre Execution Approval Objective Equipment Description Participants Log Installation Qualification Checklist Sub-Component CheckList Component Location List MOC Verification List Test / Inspection Reports Utility Verification List Attachment Log Summary, Conclusion, and Recommendation Abbreviations Post Execution Approval PRE-EXECUTION APPROVAL Prepared by By signing, the person is responsible for…
INSTALLATION QUALIFICATION OF INSPECTION CONVEYOR Contents Pre Execution Approval Objective Equipment Description Participants Log Installation Qualification Checklist Sub-Component CheckList Component Location List MOC Verification List Test / Inspection Reports Utility Verification List Attachment Log Summary, Conclusion, and Recommendation Abbreviations Post Execution Approval PRE-EXECUTION APPROVAL Prepared by By signing, the person is responsible for the accuracy…
OPERATIONAL QUALIFICATION OF DRY SYRUP FILLING AND CAPPING MACHINE (MONOBLOCK) Contents Pre Execution Approval Objectives of this Qualification Protocol Scope of this Qualification Protocol Acceptance Criteria Responsibilities Participant Log Documentation Identification Equipment Description Various Operational – n- Functionality Checks Steps involved in checking various interlocks Power & Failure & Restoration Attachment Log Recommendations Summary Abbreviations…
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Data Integrity Principle Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories should be aware that reverting from automated/computerized to manual / paper-based systems will not in itself remove the need…
