Personal hygiene checklist for employees in Pharmaceutical industry

Personnel hygiene is one of the most important parts of the Pharmaceutical industry. If personnel hygiene is not maintained in the pharmaceutical industry it may be one of the reasons for contamination of the product.

Following are the list of the thing should be maintained during person are working into the pharmaceutical Industry.

·        Do not eat and drink into the manufacturing area.
·        Do not smoke into the premises.
·        Do not Split into the premises.
·        Wear Apron and person protective equipment when entering into the Manufacturing Plant.
·        Wear the dedicate footwear or shoo cover while entering in the plant.
·        Wear the hand gloves.
·        Hair cap is compulsory while entering into the plant
·        Hair and nail shall be cut properly.
·        Jewelry and cosmetics are strictly prohibited.
·        Uniform and apron should be clean.
·        Hand shall be washed after eating and using the washroom.
·        Food and other material shall not b store into the premises it shall be stored into the dedicated Place outside the manufacturing area.
·        Clothes shall be cleaned and neat. Should not have more pockets into the apron it increases the chances of the contamination.
·        Cloth shall be clean and disinfectant regularly.
·        The person who feels ill and not feeling well should not be allowed into the manufacturing area.
·        Person who suffering from the coughing sneezing shall not be allowed in manufacturing area.
·        Person who has cut, wound or any infection shall not be allowed into the manufacturing area.

ICH Guidelines

The ICH guidelines are divided into four categories and ICH topic codes are assigned according to these categories.

Q: Quality Guideline

S: Safety Guideline

E: Efficacy Guideline

M: Multidisciplinary Guideline

Quality Guideline:

 Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Safety Guideline:

Safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

Efficacy Guideline:          

Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.

Multidisciplinary Guideline:

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

Responsibilities of Quality assurance Department in Pharmaceutical Industry

Quality Assurance department is independent of the other department but responsible for all activity and documentation performs in all departments which directly or indirectly related to the quality of the product.

Quality assurance involved in every stage and phase in the pharmaceutical industry. From the development of the drug to the distribution or dispatch of the material.

It also involves in the entire department starting from ware-house, manufacturing unit, quality control, engineering department, safety, and logistics.

Quality management system and the in-process quality assurance is the two basic area of the Quality assurance department.

Quality management system includes activities like Corrective action preventive action (CAPA), change control, Deviation, Out of specification and to comply with the regulatory requirements and evaluation.

- In process quality assurance ensures that production operations and in-process quality parameters are performed as per the requirements.

Following are the responsibilities of the Quality Assurance Department:

Quality Management System:

-Preparation, review and approval of the quality manual, Site master files, validation master plan, quality objective, and quality policy.

-To prepare review and approval of the Standard operating procedure of the quality assurance department.

-To review and approve of standard operating procedure of the other departments.

- Provide the training to concern person related to SOPs.

- To monitor activities and documents are properly perform as per the SOPs. Ensure that proper implementation of the SOPs in all departments.

-To complies the regulatory requirements as per the guideline.

-Preparation and review of the Annual product quality review.

-Register and control the change control, CAPA, deviation, OOS, OOT, etc in a proper way, and maintain the log.

-Handling of market complaints and rejection of any batches .maintain proper record of rejection and market complaint. Investigate them in proper way

-To review the change control properly and make the action plan accordingly, if required perform the risk analysis. Ensure that Proper implementation of changes and change control activity.

-To investigate the deviation and OOS in a proper manner and find out the root cause of the deviation. Proper CAPA shall be taken and implemented

-To prepare the stability schedule and stability plan.

- To prepare the validation protocol and report.

In-Process Quality Assurance:

-It include the monitoring of activities and documentation like Batch manufacturing record and batch packing record,

- Ensure that equipment usage record is properly filled

-To ensure that equipment used for the manufacturing of the product is properly cleaned. And the cleaning record of the equipment is properly filled.

- To ensure the all equipment and instrument used in manufacturing are calibrated

-Ensure that in-process sample will be sent on time and in-process quality control parameters are properly reported  

-If any deviation is observed register the deviation in proper manner and investigation of the deviation.

-Review the BMRs, quality protocols finished product.

Here we discussed the responsibilities of the quality assurance department(not limited to).

Quality assurance in Pharmaceutical Industry

Quality Assurance:

-Quality assurance is a wide-ranging concept covering all matters that individually or

collectively influence the quality of the product.

Importance of Quality Assurance

-It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore, incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.

-Quality assurance ensure that the product is consistently produced ad controlled to the quality standards appropriate to their intended use and required by the marketing authorization.

-Quality assurance plays an important role in the pharmaceutical industry. Quality should maintain in the product in every operation of the manufacturing of the product in the pharmaceutical industry not only in the finished product.

-Quality assurance is important from the development of the product to the dispatch produce from the premises in a proper way. Quality assurance is the backbone of the pharmaceutical industry.

Importance of Quality Assurance:

-Quality assurance is the department provide the good quality of the product to the patient with required efficacy and dosage.

-Quality assurance department the controlled environment for the manufacturing of the drugs.

- It complies all the regulatory requirement for manufacturing the product by following the quality standards and the guideline.

-Quality assurance department prepares and reviews the documents required in the pharmaceutical industry. and keep all the details and the record of the product manufacture in their premises

-It ensures the SOP and other procedure are followed and implemented in a proper manner and if not then proper corrective and preventive action is taken by quality assurance.

SOP on Personnel Hygiene in Pharmaceutical Industry

SOP on Personnel Hygiene

Title:

Maintain personnel Hygiene in manufacturing site:

Objective:

To maintain personnel Hygiene to prevent the contamination this may impact the quality of the product

Scope:

This procedure is applicable for all the concerning working in manufacturing Plant.

Responsibility:

All Employees:           To maintain health and hygiene in the manufacturing area.

Head of Department: To check personnel Hygiene of the person working in the manufacturing site

Head QA:                     To verify the SOP is properly followed or not.

Procedure :

- All personnel, prior to and during employment, as appropriate, should undergo health examinations.

-Personnel conducting visual inspections should also undergo periodic eye examinations.

- All personnel should be trained in the practices of personal hygiene.

-Employee suffering from any kind of sickness should inform Plant In-charge

-Any person shown at any time to have an apparent illness or open lesions that may adversely affect the quality of products should not be allowed to handle starting materials, packaging materials, in-process materials or drug products until the condition is no longer judged to be a risk.

- Personnel shall wear clean clothing suitable for the manufacturing activity.

- Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials, and intermediate or bulk product.

- Hair shall be kept clean and trimmed.

- Nails must be trimmed and shall be kept clean.

-Jewelry shall be removed for personnel engaged in manufacturing or related activities. The use of cosmetics shall be restricted.

- Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material and personal medicines should not be permitted in production, laboratory and storage areas, or in any other areas where they might adversely influence product quality. 

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Responsibilities of the Quality Assurance Department in Pharmaceuticals Industry  
Personal hygiene checklist for employees in Pharmaceutical industry

Objective of APQR (Annual Product Quality Review) in Pharma

Following the objective of the APQR (Annual Product Quality Review).

-To Verify and evaluate the the consistency of the manufacturing process ; if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process.

-To review and evaluate the quality of the product and trend of the quality of the product

-To review the trend of the yield , in process checks and Analytical results of the intermediate stage

-To review the quality of the raw material and packing ,material

-To review the details related to the quality management system (change control, deviation ,out of specification, Rejection, recall, market complaints ).

-Review of the CAPA its effectiveness.

-To review the on going stability study.

-Identify the risk related to the process, quality of the product.

-If any abnormality found in trend data based on the data process can be improved.

-It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.

-Proactively minimize risks to patients, operations, and supply chain through early detection and end‐to‐end product oversight

Steps involved in Risk assessment in Pharma

Following are the different steps of the Risk assessment

Identification of Hazards

Risk Analysis

Risk Evaluation

Risk control

SOP on Internal quality Audit in Pharmaceutical industry

Purpose:

To describe the procedure for internal quality audit to ensure implementation of cGMP and regulatory in to the premises

Scope:

This procedure is applicable all concern department where audit need to be performed.

  Responsibility:

  QA:           To prepare the audit schedule and planning of the audit

To issue required format to the auditors for preparation of audit reports and audit findings.

 Auditee:    Keep all documents easily available for auditor.  

 Auditor:    To perform fair and effective audit concern department

QA head:   To ensure activities, implementation & compliance of nonconformance.

                 To review and effective implementation of CAPA after completion of Audit

 

Procedure:

-Internal Quality System Audit shall be performed to complies cGMP requirement and effectiveness of all activity and the documentation done into the factory premises.

-The purpose of the audit is to verify the compliance of laid down quality systems and identification of areas that require focus and compliance in pharma industry. 

-Following are the different department into the pharmaceutical company where audit shall be performed (not limited to).

Store

Production

QC
Quality assurance

Microbiology

Engineering

HR

Dispatch  

-Audit schedule shall be prepared and audit shall be conducted in different department as per plan. If any deviation in audit plans it shall be recorded in audit plan schedule as remark.

-Auditor team shall be decided by QA before preparation of the audit schedule. 

-Auditors should be from the different of the department being audited.

-Audit team comprises of one team leader and other are team members. 

-Audit schedule content the audit date, in which department audit to be performed and name of the auditee and auditors.

-Internal Quality System Audit schedule shall be distributed to all concern departments before 03 days.

According to audit schedule audit shall be performed.

- Auditor shall be included following check point during Audit activity performed as per SOP, Any deviation during, review of filled documents and records ,previous audit compliance report etc.

-During Audit the effectiveness of completion of corrective and preventive action from the previous audit shall be verified.

-All observations/deviation/non-conformance observed during audit shall be documented in Internal Quality Audit Check List & Observation sheets.

All the observations are classifying as Critical, Major & Minor.

Critical observation:

The condition will seriously affect Product Quality/Patient Safety Related deficiency.The condition violates cGMP – rules and quality assurance practices.

Major observation:

The condition may affect the Significant cGMP Deficiency but with no direct impact on Product Quality /Patient Safety

Minor observation: 

The condition may not affect GMP deficiencies that are either considered to be minor isolated examples or there is insufficient information.

-All the observations / deviations/ non-conformances shall be discussed with the concerned department and documented.

-All observation and non-conformance shall be reviewed by the auditor and documented properly.

-Audit compliance report shall be prepared by the auditor.

-Head QA shall review the audit report and distributed to concern department.

 

-If any critical /major non conformance found it require the immediate corrective and preventive action.

-Auditee shall ensure that the proposed corrective action is implemented during specified time period.

-If required additional audit shall be carried out. Minimum two audits in a year shall be carried out.