Pharma Quality Desk - PQD

Introduction:      Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. Recalls also include drugs prohibited under the Provisions of Drugs & Cosmetics Act and also those products for which product licenses are suspended/cancelled.      Rapid Alert System is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. Assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or harm to animals (in case of veterinary product), consumers, operators and the environment. Background:       In the Drug and Cosmetic Act & rules, there are reference for product recall, complaint and adverse reaction in para 27 and 28 of schedule M and also condition of license for defective product recall in Rule 74(j) and Rule 78(i). Definitions: Recall...

  CONTINUED PROCESS VERIFICATION Process Validation shall be performed in three stages as:             Stage 1: Process design             Stage 2: Process qualification             Stage 3: Continued process verification   Stage 2 is already discussed. Stage 3: Continued process verification : Stage 3: Continued process verification shall be started immediately after completion of stage 2: process qualification. This stage will help in evaluating the performance of the process, identifies problems and determines whether action must be taken to correct, anticipate, and prevent problems so that the process remains in control. After completion of PPQ batches CQA and CPP data of all commercial batches including PPQ batches shall be trended in Minitab software. Once the CPP and CQA data of 30 batches includin...

Process validation Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.  Guidance for industry process validation: General principal and Practice describes process validation activities in three stages. Stage 1 Process design.: This stage is based on knowledge gained through development and scale-up activities. Stage 2 Process Qualification. : The process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.   Stage 3 Continued Process Verification.: Ongoing assurance is gained during routine production that the process remains in a state of control.  Before any batch from the process is commercially distributed for use by consumers, a manufacturer should have a high degree of assurance in the performance of the manufacturing process....