GMP Compliance Quality Systems

The image of any pharmaceutical company is solely depends how the Quality of Products is being handled and maintain through well planned, established and effective Quality Systems. Any grievances within the quality systems may lead to serious consequences and may risk the company image among customer and more import among the medical professionals.

We provide you professional review of your existing Quality systems right from review, develop action plan and implement with your team. If you are developing your company, then we are the right choice to develop your complete Quality systems as per MOH requirements and cGMP guidelines of any leading regulatory agencies. Such As FDA, Health Canada, MHRA.

Gap analysis and generation of Quality Systems
On-Site Assessment of GMP Systems of Production, Quality Control laboratory and Quality Assurance

 

Good Documentation & Archiving System

Many times peoples feel embarrassment in front of Auditor just because the old version is still present in the file along with new version of document or SOP has expired few days or even months ago and did not revise, not find correct document at right place at right time. All such common situation happened because either the documentation system is not at all established, or not implemented, or people sometime are confused what to control and what not to control, or what is the meaning of "Documentation Control" All such lapses in the Documentations system not only give embarrassment but also may lead to critical defects in product Quality and then leads to financial losses and delay in fulfilling market demands

We at Quality SolutionZ can develop/review your documentation system and upgrade as per cGMP requirements. While we are working with your Quality team, we will also train them so that they can take care of the system and maintain independently. You may contact us at any time for any specific issue and we will be advising you promptly??

 

Technical Audits

(Inspection Action plan & execution and Self-inspection)

Ideally, manufacturing facility must be operating in a manner that can be ready all the time for any kind of audit by any person. But in reality due to technical nature of the business, there are always some gray areas which must be look into before any audit. Almost all pharmaceutical units require some sort of preparation for an audit by customer and regulatory agencies national or international.

We at Quality SolutionZ can carry out preliminary audit in the light of previous audits reports and keeping in consideration the scope of the forth coming audit.
Audits conducted of your premises, processes, systems and procedures
identify weaknesses
establish required standards
practice audit technique
practice documentation retrieval
test your responses


We will prepare action plan and execute with your factory team so that they are more familiar with the requirement of an audit and can face it independently with more confidence

Self Inspection

For long term benefits, we will develop your self inspection program.

Added Value from Self-Inspections
On-site training in self inspections includes:

  • purpose of the self-inspection program
  • establishing the self-inspection program
  • setting up and training the inspection team
  • conducting the inspection
  • reporting the inspection
  • follow up to maximize advantage

Inventory System

The first reason to have a proper inventory system is to comply with the regulatory requirement. Apart from regulatory requirement, inventory system should be implemented and maintained to facilitate the smooth operation of the plant. Inventory levels also play a key role in financial terms. Inventory of materials is the dead assets of the company, higher the inventories of materials, more will the dead assets of the company.
So think about inventory system and levels that you want to maintain.3 months, 6 weeks, 4 weeks or you would like to operate at ZERO inventory levels.

 

Contact us for further details.

Secure QA Batch Release Systems

Principles of Process Flow “Pull”, not “Push” 
Build secure systems for batch release
Ensure QA staffs get all the necessary information to make secure decisions Relevant and secure batch documentation, on-time for batch disposition
Lean & secure control, Design of batch records,
Right First Time Establish
What is critical; use your process knowledge effectively within GMP compliance

Protocol for Monitoring of Water Systems

It is a fact that our planet is consist of 71% of water. We won’t be wrong if we can say that the same fact is true in case of pharmaceutical & food industry. Water is the only common and most abundantly used ingredient in manufacturing units. Without water it is almost impossible to run the factory just like life, impossible without water.

We put all our efforts to control water in raw materials, we all need our packaging materials free from water, we are very much concerned about the vapors of water present in manufacturing environment. This is all because water may leads to the deterioration of materials and can provide favorable condition for the proliferation of contaminants but people pay less attention to control the Quality of Water, I rather must say waters.  I have seen many facilities with state-of-the-art water purification plants with very poor control and monitoring system after purification. Just because they do not have comprehensive monitoring program, most of the time quality of water is not certain and heavy financial and resource losses have to be tolerated.

Water is very good source of nutrients and a very excellent medium; most of the time microbial contamination is more likely to take place as compare to Chemical contamination except in case of Water for injection, microbial contamination also triggers the chemical contamination (excretion of wastes by microbes and break down of cell wall). Water Quality is a major challenge. A minor fault may lead to the contamination of products, areas, systems, and even create health hazardous to staff.  Therefore, monitoring of water system should be well thought and should be based on logic and scientific data.

Let’s give us a chance to review your water system and design monitoring protocols so that you may feel comfortable all the time about the quality of water available and you are also saving valuable resources.

Environmental Monitoring Program

Environmental monitory of manufacturing areas not only a mandatory requirement to assure quality of end products but also tells you how effective your systems are. Such as air handling system, dust extraction system, cleaning procedure & their frequencies, type, concentration and change frequencies of disinfectants, so on and so forth. All such system are more critical in case of sterile areas especially for aseptic operation where no sterilization of finished products at the end of the process.

Monitoring of chemical contaminants, commonly active pharmaceutical ingredient (API) in manufacturing environment is also mandatory. In multi purpose area you need to prove that there is no cross contamination from previous product OR if a drug substance is very potent and need to established Occupational Exposure Limits (OEL).

 

Secondly, the data of environmental monitoring depends what are the techniques applied, design of monitoring program and most importantly the training of analyst.  All such factors play an important role and reflected in the data.

Validation Master Plan (VMP) & Validation Protocol

Now all stake holders realized the importance and benefits of validation to maintain consistence quality of finished products. Not only in pharmaceutical industry it is compulsory requirement for almost all kind of industries. Although initial cost of validation is high but long term benefits pay back initial cost and in reality it is a long term saving in overheads and operational cost of the plant.

We have first hand experience in preparing VMP and validation protocols for almost all class of manufacturing areas, equipments, systems, processes and methods.
Provide us an opportunity to prove our-self

Annual Contract

We offer annual contracts for

  • Expertise opinion "on an occasional or as-needed basis"  
  • Contract Quality Person - Quality System review and successful regulatory inspections
  • Quality Audits as per cGMP of manufacturing areas, warehouse, QC lab, QA compliance
  • Product Reviews to improve quality and reduce cost

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