Thursday, July 16, 2020

Why training is essential part in Pharmaceutical Industry and steps to deal with it

Why training is essential part in Pharmaceutical Industry and steps to deal with it

Training is one of the essential elements of the Pharmaceutical and Biotechnology Industry as it gives perfection in the skill of the employee to understand the process and to help in investigation of any issue occurring.

For example, if the weight variation is occurring in the running machine, only understanding and the skill of the operator can resolve the issue on the spot. This can happen only when the operator for a supervisor has good training about the subject. Furthermore, inadequate training contributes to process and product variability.

CFR 211.25 Personnel qualifications says “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions”. Therefore, putting any person on a job in the pharmaceutical or biotechnological industry, it is necessary to have his or her complete training and evaluation about his job responsibilities. Life science companies that embrace and implement a quality culture ensure employees are optimally trained before touching the product, therefore safeguarding and protecting the health and well-being of the general public.

To accomplish this, an integrated quality/human resources (HR) systems approach is recommended for the development and deployment of training. The training should be implemented in pre-defined SOPs and Evaluations. To develop an effective training program the following steps should be followed.

  1. Identify needs – engaging management and staff

To develop any training program, it is essential to understand the requirement of a person coming for a job or responsibility by management or supervisor to take care for making the process or subject clear and the people can do their job with proper understanding and skill.

  1. Identify Subject Matter Experts (SMEs)

SMEs are the experts for the subject responsible for giving complete training and understanding of the job and responsibilities. They are also responsible for designing training programs and evaluating the protocols. To keep an eye on the training programs happening, which are in-line to the business requirements. Therefore, they are effective in performing technical and skills training, sharing knowledge and information, and transferring learning.

  1. Preparing a steering committee for action

Group of cross-functional department team, where each one has expertise in their own field forms a steering committee. The committee should be knowledgeable of the strategic implications of the training and its related outcomes.

  1. What is current state assessment

Responsibility of the steering committee is used to evaluate what is the current situation of training in the unit. Routine they have to evaluate the skill, the program Evaluation of people working on the shop floor.

  1. Identify strengths and gaps
In routine or in case of any issue, management and subject matter experts have to identify the gaps by doing investigation. During the investigation they have to find out the strength and weakness of the system and appropriate CAPA (Corrective and preventive action) is required to fulfill non-occurrence of the issues.
6.     Training module development team formation

             On the basis of Investigation and CAPA requirement, the subject expert has to prepare a module depending

             on the gaps identified for the weakness found in the system. 

  1. Module development

Important is to identify the training support material or resources required to reinforce each module for example SOP basic concepts etc. Selection of staff should be done on the basis of their skill in the subject or process. As per Training Need Identification (TNID) matrix, module training should be given to the people.

  1. Pilot study of module 

Each module should be evaluated for its clarity, accuracy and performance requirement. To conduct a pilot study, trainers should be certified for the revaluation. 

  1. Feedback and review for finalization of module 

Before going to the finalization of the module, evaluation and assessment of pilot protocol should be taken from the supervisors for experts. The further requirements of the module and training of the changes should be given to the user. 

  1. Finalize the modules and conclusion 

Once the pilot module is completed the final approved module should be published for the activity and training should be imparted.

 

Effectiveness of the training imparted is must and should have periodic evaluation to understand the people have understood the module requirement and following SOPs instructions as per changes occurred and no further issue occur in future due to previous deviations or CAPA taken.


Further any query can be put into comment section or write to author at simcopharma5@gmail.com

Monday, July 13, 2020

Positive Control Samples For Parenteral Product Classes When Validating A Leak Testing Method

Dear Readers,


Are you looking for positive control preparation for validating leak test in the parenteral dosage forms? Here is sharing for the same, go to the video base presentation which is helpful to understand the philosophy and phenomena.  


Validating A Leak Testing Method For Parenterals 

Training cum Seminar at Enrise By Sayaji, Indore

  A great training cum seminar session was conducted for  Contamination Control Strategy  (CCS - Annex 1) and Disinfectant validation. Appre...