Trek Pharma

  INTRODUCTION In the complex field of pharmaceutical manufacturing, it is important to have a sound quality system in place to make sure that products manufactured have the desired quality, safety and efficacy.  At the same time, it is vital to recognize that even the best quality system is only as good as the people who make it work.  Personnel are the backbone of the manufacturing unit, and there must be a sufficient number of adequately qualified and trained staff to ensure one achieves the desired quality products.  No person should be so burdened with responsibilities that it presents a quality risk. ORGANIZATION Sufficient number of personnel must be present to perform as well as to supervise the manufacture, processing, packing and holding of every drug product.  In any pharma unit, it is important to lay out individual responsibilities in a manner that is clear enough to be understood by the personnel who are to perform the respective tasks. ...

    INTERNATIONAL STANDARD ORGANIZATION (ISO) ¨    OVERVIEW OF ISO ¨    AIMS OR ISO ¨    PRINCIPLES OF ISO ¨    ISO 9000 ¨    BENEFITS ¨    ELEMETNS ¨    STEPS FOR REGISTRATION PROCESS ¨    ISO 14000 ¨    BENEFITS ¨    DIFFERENT BETWEEN ISO 9000 & 14000   OVERVIEW OF ISO ISO is a name used for the international organization for standardization .  It is derived from the Greek word “isos” that means equal.   From the 25 members who met to initiate this process, ISO has grown to a huge network of more than 160 member countries who represent their nation's standards organizations.  The 150 headquarters is located in Geneva, Switzerland.  The ISO is considered the world's largest organization involved with developing voluntary international standards.  In this role, the ISO helps to facilitate global trade by creating com...

  QUALITY BY DESIGN TOOLS Quality by Design relies on the use of certain tools. These include prior knowledge, risk assessment, mechanistic models, design of experiments and data analysis, and process analytical technology.  Prior Knowledge According to ICH rules, prior knowledge includes information, knowledge, or skills that have been taken up via prior experience with processes identical to those in question and published data. The tool can be used from the start of the development process and updated on a regular basis applying the data produced by the process. In respect to QTPP and CQAS, prior information may be used as part of control techniques. However, it's crucial to avoid placing an excessive amount of dependence on existing information because doing so might give up control over the production process. Instead of creating data from scratch, it is preferable to make use of this tool to confirm existing information. Risk Assessment Prior to develop...

  QUALITY BY DESIGN(QbD) ¨     DEFINATION OVERVIEW MAIN GOAL ELEMENTS TOOLS  DEFINITION The ICH guideline Q8 (R2) Pharmaceutical Development defines the term Quality by Design (QbD) as “a systematic approach to development that begins with predefined objectives emphasizes product process understanding and process control, based on sound science and quality risk management (QRM).” OVERVIEW QbD main goals: Obtaining meaningful quality requirements for the product based on clinical effectiveness. By increasing the process and product design and control, we may increase process capability while lowering product issues and variability. To encourage root cause investigation and control any modifications made to a medicine after it has received approval. To increase the effectiveness of the production and product development processes. As a result, the first step in the pharmaceutical QbD method is to identify the crucial quality attributes from...