Quality Operations Procedures for Pharmaceutical, API, and Biotechnology
Quality Operations Procedures for Pharmaceutical, API, and Biotechnology
Click to enlarge
Author(s): Haider, Syed Imtiaz
ISBN No.: 9781439886908
Pages: 584
Year: 201206
Format: Trade Cloth (Hard Cover)
Price: $ 231.76
Status: Out Of Print

Handling of Sampled Material Control of Incoming Materials used in Production Control of Bulk and Intermediate Products Checking of Finished Products Destruction of Disposal Samples after Complete Testing and Reference Samples after Expiry Recording the Analysis and Controlling the Analytical Registers and Records Testing of Finished Products Microbiological Monitoring Program Clothing in Microbiology Laboratory Microbiological Media Handling General Cleaning and Sanitation of Microbiological Laboratory Managing Primary and Secondary Reference Standards in the Quality Control Laboratory Handling of Raw/Packaging Materials and Finished Samples in Reference Room Stability Testing Program Control of Controlled Substances (Raw Material, Bulk and Finished Products) Rounding of Significant Numbers Analytical Methods Transfer for New Products Handling Out of Specification Results Batch Auditing Procedure Validation and Certification Guidelines Product Complaints Handling Procedure Sampling of Finished Products for Laboratory Testing Sampling of Bulk Products for Laboratory Testing Product Recall Procedure Cream/Ointment In-process Audit Checks Inspection of Physical Attributes/Characteristics of Coated/Uncoated Tablets Powder In-Process Filling Audit Checks Sealing Checks of Strips and Blisters Tablets Compression Audit Checks In-Process Checks for Finishing Lines Internal QA Audit Guideline Suppository Fill Weight and Physical Attributes Check Tablets/Capsule Filling In-Process Audit Checks Physical Inspection of Attributes of Capsules Capsules In-process Audit Checks Liquid Products In-Process Audit Checks Document Security & Control and Good Documentation Guidelines Labeling for Incoming Materials, In-Process Products and Complete Processed Products Pre-Inspection Audit Guidelines for ANDA Products Operational Qualification Guideline The Retention of Records and Documents Good Manufacturing Practices in the Premises Labeling for Incoming Materials, In-Process Products and Complete Processed Products Random Sampling Physical Characteristics Check of Product and Foil during Sealing Raw Material QA Audit Checks Incidence Citation Report Technical Documents Distribution Control Key Performance Indicator Vendor Evaluation and Approval Procedure cts Handling Out of Specification Results Batch Auditing Procedure Validation and Certification Guidelines Product Complaints Handling Procedure Sampling of Finished Products for Laboratory Testing Sampling of Bulk Products for Laboratory Testing Product Recall Procedure Cream/Ointment In-process Audit Checks Inspection of Physical Attributes/Characteristics of Coated/Uncoated Tablets Powder In-Process Filling Audit Checks Sealing Checks of Strips and Blisters Tablets Compression Audit Checks In-Process Checks for Finishing Lines Internal QA Audit Guideline Suppository Fill Weight and Physical Attributes Check Tablets/Capsule Filling In-Process Audit Checks Physical Inspection of Attributes of Capsules Capsules In-process Audit Checks Liquid Products In-Process Audit Checks Document Security & Control and Good Documentation Guidelines Labeling for Incoming Materials, In-Process Products and Complete Processed Products Pre-Inspection Audit Guidelines for ANDA Products Operational Qualification Guideline The Retention of Records and Documents Good Manufacturing Practices in the Premises Labeling for Incoming Materials, In-Process Products and Complete Processed Products Random Sampling Physical Characteristics Check of Product and Foil during Sealing Raw Material QA Audit Checks Incidence Citation Report Technical Documents Distribution Control Key Performance Indicator Vendor Evaluation and Approval Procedured Documentation Guidelines Labeling for Incoming Materials, In-Process Products and Complete Processed Products Pre-Inspection Audit Guidelines for ANDA Products Operational Qualification Guideline The Retention of Records and Documents Good Manufacturing Practices in the Premises Labeling for Incoming Materials, In-Process Products and Complete Processed Products Random Sampling Physical Characteristics Check of Product and Foil during Sealing Raw Material QA Audit Checks Incidence Citation Report Technical Documents Distribution Control Key Performance Indicator Vendor Evaluation and Approval Procedure.


To be able to view the table of contents for this publication then please subscribe by clicking the button below...
To be able to view the full description for this publication then please subscribe by clicking the button below...