Deviation Handling and Quality Risk Management (Part – I)

Deviation Handling and Quality Risk Management Purpose The aim  is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations.  The intent is to support effective and timely implementation of tools related to deviation management encountered during vaccine and biologicals manufacturing. … Read more

Question ans Answer on Cleaning validation in Pharmaceutical Industry

Question 1. What Is Cleaning Validation? Answer:   To evaluate the capability of cleaning procedure  in removing the drug residue and microbiological bio burden on equipment within established acceptance criteria, through the validation of cleaning procedures. To establish sufficient documented evidence to assure that, cleaning procedures can repeatedly and reproducibly remove residue of the subjected product … Read more

Master Plan or Protocol for Process Capability Design and Testing

Master Plan or Protocol for Process Capability Design and Testing Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-process, finished product Definition of process output Potency, yield, physical parameters Definition of test methods Instrumentation, procedures, precision, and accuracy Process analysis Process variables, … Read more

Code to Code Transfer of Materials and Additional Testing of Materials / Products

Code to Code Transfer of Materials Objective (procedure) To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard operating procedure is applicable at formulation plant . Responsibility … Read more

SOP on In-process sampling of semi-finished product

SOP on In-process sampling of semi-finished product Objective: To lay down procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product  in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished product samples. Production personnel are responsible … Read more

SOP on execution of exhibit batches

SOP on execution of exhibit batches  Objective To lay down a procedure for execution of exhibit batches. Scope This SOP is applicable for execution of exhibit batches to formulation plant of Pharmaceutical company. Responsibility Officer/above of production and quality assurance department shall be responsible. Accountability Head of Department shall be accountable for compliance and implementation … Read more

SOP on withdrawal, storage, observation & destruction of control / retention sample

SOP on withdrawal, storage, observation & destruction of control / retention sample Objective: To lay down the procedure for withdrawal, storage, oberservation & destruction of control / retention sample from production (Oral & Injectable), Q.C. (RM Retention) . Scope: This SOP applicable for withdrawal, storage, observation & destruction of control sample from production (Oral & … Read more

SOP on preparation, control, issuance and revision of Batch Manufacturing and Batch Packing Records

SOP on preparation, control, issuance and revision of Batch Manufacturing and Batch Packing Records Scope: This procedure is applicable to the manufacturing & packing records being generated at the formulation Plant of Pharmaceutical company. Responsibility: Executive Production – Preparation of BMR / BPR. Head Production / nominee – Checking / Review of BMR / BPR. … Read more

SOP on line clearance

SOP on line clearance Objective:To lay down the procedure for line clearance of manufacturing, warehouse . This is to ensure that the start up of any production/ process is free from previous material/contaminants.  Scope: This SOP is applicable for line clearance of production (oral), warehouse areas of Formulation plant. Responsibility: Operator/ Supervisor shall be responsible … Read more

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