Applied Learning

Training of staff is an integral part of current Good Manufacturing Practices and Quality Management Systems because it enhances their knowledge to provide better understanding of current Good Manufacturing Practices and Pharmaceutical Quality Management System. These trainings not only help them to understand the importance of their role in the organization and enable them to work with efficiency and compliance. This, on the other hand, is helpful for the organization to maintain GMP and regulatory compliance.

We offer trainings for workforce and professionals working in the GMP environment. Our training contents are based on authentic information, and current guidelines and standards and are designed to deliver practical and up-to-date knowledge. These enable them to enhance their knowledge and utilize it while carrying out their assignments. These trainings are beneficial for both, the organizations and the individuals.

Benefits for organizations

Saving cost
Increasing productivity and profitability
Minimizing errors
Improving compliance
Enhancing quality of products

Benefits for individuals:

Keeping knowledge Up-to-date
Carrying out the assignments in right way
Increasing productivity
Enhancing skills
Better opportunities and growth

Trainings offered by PHARM-serve include, but not limited to, the following topics:

Good Manufacturing Practices for Workforce

Workforce is the backbone of every organization as they are the working hands who carry out tasks under supervision. The contents of this training are designed to provide up-to-date-knowledge and easier understanding of cGMP. This training will help the individuals to comply with cGMP while carrying out their day-to-day tasks. This is beneficial for the organization in implementing, maintaining and increasing cGMP compliance productivity and ultimately the quality of products is enhanced. in easy way, so that, they can grab the understanding. This helps the individual to comply GMP while carrying out the tasks. This is beneficial for the organization in implementing, maintaining and enhancing cGMP and the quality of products and increasing productivity.

Good Manufacturing Practices for Pharmaceutical Professionals

Training can be provided on many aspects of cGMP (Area design and qualification, formulation development, development of manufacturing process, storage and dispensing, quality assurance and quality control, warehousing etc.) The contents of training will be designed to provide current knowledge GMP regulations and guidelines and fulfilling needs of individuals and the organizations. These trainings will enable professionals to understand, implement and improve compliance in organizations they serve. On the other hand organizations are benefited through increased cGMP compliance, quality of products and productivity.

ISO/IEC 17025

ISO/IEC 17025 enables the laboratories to demonstrate their competence and global acceptance of their test results and hence saves the burden of getting the product tested by third-party laboratories while exporting the products. This standard provides tools and mechanisms to assure the quality of tests and calibrations results. The contents of training will help the organization to understand the requirements of the standard. This is helpful in designing procedures meeting the requirements of the standard. to design (or integrate) the management system of the laboratory integrated with other management systems like ISO-9001, 14001 etc.

Qualification of Analytical Instruments

Reliability and accuracy of analytical data is critical which cannot be assured until the analytical instruments are not qualified. Qualification is a set of activities which include (Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Routine Maintenance, Requalification and Periodic Calibration. These should be supported with valid documentary evidence. Typically, DQ, IQ and IQ are provided by the manufacturer of the instrument while PQ, maintenance and calibrations and requalification are the user's responsibilities. This training aims to enable the management of laboratories to qualify their instruments and hence scientific justification for correctness and acceptance of measurement results.

Validation / Verification of Analytical Methods

Analytical results of laboratory obtained through the methods either developed by the laboratory and not validated or official methods (or methods developed or validated by other laboratory) but not verified; have no scientific justification to be accepted, are not trustworthy and waste of resources and not fit for release of pharmaceutical products. Validation or verification of analytical methods is another aspect essential to reliability of test results. Validation or verification of analytical methods must be supported with documentary evidence and the data must be statistically valid for its acceptability. There are many aspects which are to be addressed while analytical methods are being validated or verified.. This training is designed to provide understanding theoretical concepts and their practical application in preparing protocols, performing validating / verifying analytical methods, analyzing and reporting results in accordance with international guidelines and compendial requirements.

Estimation of Measurement University in Testing and Calibration

This is one of the mandatory requirements for accreditation to ISO/IEC 17025. Measurement uncertainty is property associated with the measured value or result of measurement activity. This estimation includes evaluation of factors associated with sources involved in measurement. This is a decisive factor in deciding if the results of measurement are within the limit or are outlier. The training will provide understanding of theoretical concepts with practical application in real life.

In-Vitro Pharmaceutical Equivalence

It is also known as Comparative Dissolution Profile (CDP). Generic drug products must necessarily be bioequivalent to innovator (reference) products. Which is established through costly bioequivalence (BE) studies. The drugs are categorized into four classes; out of which biowaivers are possible for two classes of drugs if their in-vitro pharmaceutical equivalence is established. This in-vitro pharmaceutical equivalence is established through comparison of dissolution patterns of test product with innovator (reference) product. There are many critical factors that, if ignored, can falsify the results of in-vitro dissolution profile. If the product’s dissolution profile fails it must be proven bioequivalent through costly bioequivalence studies and even there are large possibilities of failures in BE studies. In this training knowledge will be provided to understand these critical factors while performing the studies so that these in-vitro equivalence studies can be prevented from failures.

Good Practices in Testing and Calibration

There are numerous mistakes in testing and analysis which are neglected due to lack of awareness. The contents will be helpful for laboratory personnel, specially those who are at the beginning of their career in the field of quality control laboratory testing and analysis to understand how to perform assignments so that their analytical reports are considered trustworthy. This training will enable them to self-correct themselves and produce correct results in optimum time. Hence resources wasted in investigating out of specification results and repeated analysis would be saved.

Data Integrity

Integrity of GxP data is important which is addressed in many GMP regulations across the globe. Due to its increasing importance Integrity of data and information has been addressed in international standards of ISO and other international guidelines. It is required that the data and records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available throughout its lifecycle. In international inspections and audits along with compliance prime importance is being given to data integrity. Hence, understanding of data integrity is essential and must be maintained. Data integrity is achievable through compliance of policies and procedures established in the light of the regulations, guidelines and standards. Based on guidelines and standards this training will deliver knowledge to establish policies and procedures for maintaining integrity of data.

Out of specifications investigations

When results fall outside their specified limits; it is necessary that thorough investigation is carried out to find out the root cause of failing results. In QMS repeat testing or retesting is not allowed until it is fully investigated and root cause is identified. The investigation should be systematic and documented. Repeat testing or retesting is permitted when necessary. The training is designed according to the current guideline and will help the personnel investigating OOS to design the procedures and for effective investigations.

ICH (Quality) guidelines

International Council for harmonization (ICH) issues hormonized guidelines

Quality Risk Management

Risk management has been an integral part of nature but has diverse aspects. To the term “Risk Management” the prefixed “Quality” is added to make it focused on quality in products and services. Quality Risk Management has become an integral part of quality management systems and has gained importance in recent years. Good understanding of QRM helps to identify potential hazards, prioritize them for taking action to prevent or reduce occurrences or their harms, thus resources and lives are saved. This training gives learning to various techniques supported with various examples used for QRM and will enable the participants to easily adopt in their assignments.