Pharmaceutical Quality Assurance

Quality Assurance (QA)

Quality Assurance is the sum total of the organized arrangements made with the object of ensuring that products will be the quality required by their intended use.

It is a planned and systematic set of activities necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. 

QA = Product design + GMP + QC + Quality Goal Activities

Responsibilities of Quality Assurance Department

⇨ Ensuring fulfillment of regulatory requirements.

⇨ Establishing specifications and control procedures for all starting materials, intermediates and finished products.

⇨ Arranging quality audit visits to suppliers and self-inspection.

⇨ Monitoring of the systems to ensure implementation of GMP & GLP in routine operation.

⇨ Ensuring a suitable product quality review system exists.

⇨ Establishing manufacturing methods and SOPs covering entire operations and their regular updating.

⇨ In-Process checking of manufacturing operation of production area to ensure compliance with SOP.

⇨ Ensure appropriate sampling of Bulk and Finished products as per sampling plan for QC Analysis.

⇨ Perform the management of retention sample.

⇨ Verify the rules of GMP & GLP, products safety and hygiene and also personal hygiene during work in progress.

⇨ Train up the personnel as per cGMP and others guidelines.

⇨ Perform and monitor the validation and calibration activities.

⇨ Monitor temperature and humidity in all areas of activities.

⇨ Handle the non-conformities, customer complaints, change control and deviation management.

What are the Competencies require for working in Quality Assurane?

Answer:

Competencies fequire for working in Quality Assurance:

⇨ Adequate Academic Knowledge

⇨ Adequate knowledge about GMP and Regulatory Requirements.

⇨ Sufficient knowledge about Production Process & Analytical Works.

⇨ Proper Job knowledge and Experiences in the relevant field.

Difference between QC and QA

Quality Control	Quality Assurance
QC is the operational technique and activities that are used to fulfill requirements for quality.	QA is a planned and systematic set of activities necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.
QC = Testing + Assessment	QA = Product design + GMP + QC + Quality goal activities.
QC is an activity that verifies if the product meets pre-defined standards.	QA is an activity that establishes and evaluates that process to provide the products.
QC implements the process.	QA helps establish the process.
QC is responsibilites of the tester.	QA is the responsibilites of the entire team.
QC improves the development of a specific peoducts service.	QA improves the process that is applied to multiple products that will ever be produced by a process.

See also:

What do you by Quality by Design (QbD)? What is the advantage of QbD?

Quality Target Product Profile (QTPP)

Quality Target Product Profile is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy. It provides an understanding of what will ensure the quality, safety, and efficacy of a specific product for the patient. It describes the design criteria for the product and should therefore form the basis for development of the CQAs, CPPs and control strategy.

Critical Quality Attributes (CQA)

Critical Quality Attributes is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range or distribution to ensure the desired product quality (ICH Q8).

Critical Process Parameter (CPP)

Critical process parameter is process parameter whose variability has an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality (ICH Q8).

Critical Material Attribute (CMA)

Critical Material Attribute is a physical, chemical, biological or microbiological property or characteristic of an input material that should be within an appropriate limit, range, or distribution to ensure the desired quality of output material.

Process Analytical Technology (PAT)

PAT refers to a method or system of testing. According to the FDA, it is essential for "designing, analysing, and controlling manufacturing". It involved taking measurements of the attributees described in the terms above, i.e. CQAs, CPPs, and CMAs.

See also:

Factors Influence the Quality of Pharmaceutical Finished Products

Validation

In 1987 the FDA in its proposed guidelines has offered the following definition for validation:

Validation is establishing documented evidence that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting its pre-determined acceptance criteria.

Phases of Validation

The activities of relating to validation studies may be classied into three phases:

Phase-1: Pre-Validation phase or Qualification Phase, which provides all activities relating to product research and development, formulation, pilot batch studies, scale-up studies, transfer of technology to commercial scale batches, establishing stability conditions, storage and handling of in-process and finished dosage forms, Equipment Qualification, Installation Qualification, Operational Qualification, Master Production Documents, Process Capability.

Phase-2: Process Validation phase or Process Qualification phase, designed to verify that all established limits of the Critical Process Parameters are valid and that satisfactory products can be produced even under the "worst case" condition.

Phase-3: Validation Maintenace phase, requiring frequent review of all process related documents, including validation audit reports to assure that there have been no changes, deviations, failures, modifications to the production process and that all SOPs have been followed, including Change Control Procedures.

Divisions of Validation

The field of validation is divided into a number of subsections including the following:

1) Cleaning Validation

2) Process Validation

3) Analytical Method Validation

4) Computer system Validation

* Why validation becoming mandatory for Pharmaceuticals?

Now-a-days validation of all major pharmaceutical system & process are very essential. It ensures the quality of manufactered products and helps yo manufacture the quality prducts. Validation is a regulatory requirement of FDA, MHRA, TGA, DGDA and other regulatory agencies in the world. These agencies focus on the validation of different systems and processes during their regulatory and GMP audit.

Above mention benefits of validation, it goes without saying validation becoming mandatory for pharmaceuticals.

CIP (Clean in places)

CIP is generally refers to the automated circulation system. Some of the critical aspects of the CIP system that need to be considered are the certainly of preventing backflow and of assessing the suitability of recirculated cleaning solution for subsequent use. CIP parameters such as flow rate, pressure and spray ball pattern must also be qualified prior to use. CIP can be implemented to clean vessels, interior surfaces of pipes, filters, process equipments and fittings, without disassembly.

Advantages of CIP

⇨ Good reproducibility of the cleaning process because the cleaning parameters are defined.

⇨ Dismounting of equipment is not necessary.

⇨ Low number of personnel.

Disadvantages of CIP

⇨ Usually high consumption of water and cleaning agent.

Working steps of CIP

⇨ CIP system selection

⇨ Piping networking plan

⇨ CIP SKID configuration

⇨ CIP cycle operational parameter setting

⇨ Validation and automation system strategy

⇨ Key Check points for supplier selection.

Cleaning Validation

Cleaning Validation is a documented evidence to ensure that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration i.e. batch size, dosing, toxicology, equipment size etc.

Cleaning Validation Methodology

Claleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as GMP requirement. The FDA has strict regulation about the Clening Validation. FDA also requires firms to conduct the validation studies in accordance with the protocols and to focument the results of studies. The validation of cleaning validation is also regulated strictly,  which usually mainly covers the aspects of equipment design, cleaning process written, analytical methods and sampling.

Process Validation

Process Validation is a documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specification and quality characteristics.

Types of Process Validation:

Depending of when it is performed in relation to production, Process validation can be of three types:

1) Prospective Validation (Development Stage)

2) Concurrent Validation (Production Stage)

3) Retrospective Validation

4) Revalidation

Prospective validation

Prospective validation is carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps. These are then evaluated on the basis of past experience to determine whether they might lead to critical situations.

In prospective validation, an experinental plan called the "Validation Protocol" is executed before the process is put into commercial use. 

In prospective validation Number of Batches: 3 Consecutive Batches.

Concurrent validation

Concurrent validation is carried out during nornal production. This method is effective only if the development stage has resulted in a proper understanding of the gundamentals of the process. The first three production-scale batches must bbe mpnitored as comprehensively as possible. Concurrent validation together with a trend analysis including stability should be carried out to an appropriate extent throughout the life of the product. Concurrent validation may be the practical approach under certain circumstances. Number of Batches: 3 consecutive batches (For special case, 1 batch.)

Retrospective validation

Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures and equipment remain unchanged. Such experience and the results of in-process and final control tests are then evaluated. Recorded difficulties and failures in production are analyzed to determine the limits of process parameters. It is important to analyzed 10 to 25 batches manufactured over a period of 12 months to provide a statistically significant picture. It is not the preferred method of validation and should be used in exceptional cases only.

Number of Batches: 10 to 25 batches

Revalidation

Revalidation provides the evidence that changes in a process and/or the process environment that are introduced do not adversely affect process characteristics and product quality. Periodic review and trend analysis should be carried out at scheduled intervals. Revalidation becomes necessary in certain situations.

Number of batches: Depends upon Risk Analysis.

See also:

Why do we consider three consequitive batches for process validation? Why not two or four?

Benefits of Validation

⇨ Increased rate of production

⇨ Reduction in rejection and reworks.

⇨ Reduction in utility costs.

⇨ Fewer complaints about process related failures.

⇨ Reduced testing in process and finished goods.

⇨ More rapid and accurate investigations into process deviations.

⇨ More rapid and reliable startup of new equipment.

⇨ Easier scale-up from development work.

⇨ Easier maintenance of the equipment.

⇨ More rapid automation.

⇨ Improve emploee awareness of processes

See also:

What are the Critical Parameters affecting Process Validation?

Method Validation

Method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. The validation of an analytical method is the process by which it is established by laboratory studies that the performance characteristics of the method meet the requirment for the intended application.

Analytical Method Validation

The principal purpose of analytical method validation is to confirm that the selected analytical procedure employed for a specific test is suitable, reliable and accurate for the intended analytical application.

See also:

Analytical Performance Parameters used for the purpose of Method Validation

Differences between Method Validation, Method Verification and Qualification

Method Validation: Full validation required for in-house methods, generally specificity, linearity, accuracy, repeatability, intermediate, precision plus for purity: LOD/LOQ

Validation is both a,demonstration that your lab can run the method and that the method or change to a method is fit for purpose.

Method Verification: Required for most compendial methods. Verification is a demonstration that your laboratory can pergorm a Standard Method or other well documented methof and produce acceptable results.

Equivalency: Required for an in-house method, when compendial standard is claimed.

Hold Time:

Hold time can be considered as the established time period for which materials may be held under specified contidions and will remain within the defined soecifications.

Hold Time Studies

Hold time studies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not degrade significantly during the hold time at a required temperature and Relative Humidity.

Which Stages shall be considered for Hold Time Study?

Answer: The following stages shall be considered for Hold Time Study:

<table>

<tbody>

<tr>

<th>Processing Step</th>

<th>Product</th>

</tr>

<tr>

<td>Binder preparation to granulation</td>

<td>Granulate</td>

</tr>

<tr>

<td>Wet granulation to drying</td>

<td>Drird granulate</td>

</tr>

<tr>

<td>Dried granulate to Lubrication/Blending</td>

<td>Lubricated Blend</td>

</tr>

<tr>

<td>Blend to Compression</td>

<td>Compressed tablets</td>

</tr>

<tr>

<td>Blend to Capsule filling</td>

<td>Filled Capsule</td>

</tr>

<tr>

<td>Compression to coating</td>

<td>Coated Tablets</td>

</tr>

<tr>

<td>Coating solution to preparation</td>

<td>Coating solution</td>

</tr>

<tr>

<td>Coating to packing</td>

<td>Finished Packed</td>

</tr>

</tbody>

</table>

Qualification

Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended.

Equipment and Facility Qualification: Stage of Validation

Equipment and Facility Qualification is fequired to provide a high level of documented evidence that the equipment and the process conform to a written standard to get quality final product. Validation of pharmaceutical process equipment involves the following: 

Design Qualification (DQ)

Design qualification is used at the stage where a design that has been developed from the VMP, cGMP and other Health and Safety guidelines, is reviewed and documented by competent persons to ensure that the design equipment,  if built, will satisfy all the detailed specified requirements.

The design qualification js the only document that is going to confirm that the design will work.

Installation Qualification (IQ)

The performance of tests to ensure that the installations such as machines, measuring devices, utilities and manufacturing areas,  used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.

Operational Qualification (OQ)

The documented action of demonstrating that the process equipments and ancillary systems work correctly and operate consistently in accordance with  established specifications.

The operational qualification includes a review of the standard operating procedure for start up, operation, maintenance, safety and cleaning.

Performance Qualification (PQ)

PQ ensures that the system/equipment perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data

Results must demonstrate that performance consistently meets pre-determined specifications under normal conditions and where appropriate for worst case situations.

Maintenance Qualification (MQ)

Component Qualification (CQ)

Instruments Re-qualification

See also:

⇨ Which Parameters shall be considered for Facility Qualification in Pharmaceuticals?

⇨ Difference between Validation and Qualification

Water System Qualification

Water system Qualification is the process of establishing that a water system consistently produces water that meets quality standards. This is done through sampling, testing and monitoring the system.

The goal of water system qualification is to ensure that the system consistently deliver water that meets quality standards through its lifecycle.

Specifications for USP Grade Purified water and WFI:

A. Specifications for USP Grade Purified Water:

1. TDS: 10mg/L

2. Electrical Conductivity: 1.30 uS/cm

3. TOC: 500 ppb

4. pH: 5.0 to 7.0

5. Chlorides: 500 ppb

6. Ammonia: 300 ppb

7. Bacteria Alert (FDA): 100 cfu/ml

8. Endotoxins: 0.25 EU/ml

9. Final Purification process: Any

B. Specifications for USP Grade Water for Injection:

1. TDS: 10 mg/L

2. Electrical Conductivity: 1.30 uS/cm

3. TOC: 500 ppb

4. pH: 5.0 to 7.0

5. Chlorides: 500 ppb

6. Ammonia: 300 ppb

7. Bacteria Alert (FDA): 10 cfu/ml

8. Endotoxins: 0.25 EU/ml

9. Final Purification process: Distillation, Reverse Osmosis

Deviation

A deviation is a departure from standard procedures or specification resulting in non-conforming material and/or processes or where there have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety. For compliance to GMP and the sake of continuous improvement, these deviations are recorded in the form of Deviation Record (DR).

Classification of Deviation

Deviation can be of two different types:

1) Planned Deviation

2) Unplanned Deviation

Unplanned deviation may be various types. Such as:

1) Critical Deviation

2) Major Deviation

3) Minor Deviation

Critical Deviation: 

When the deviation affects a quality attributes, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients is highly probable, including life threatening situation, then this type of deviation is referred to as Critical Deviation.

Examples of Critical Deviation:

⇨ Manufacturing instructions are not followed.

⇨ Wrong batch details are printed.

⇨ SOPs or Methods of testing are not followed during analysis.

Major Deviation:

When deviation affects a quality attribute, a major process parameter, an equipment or instrument critical for process or control of which the impact to patients or personnel or environment, then this type of deviation is categorised as Major Deviation.

Examples of Major Deviation:

⇨ Line Clearance is not yltaken from QA

⇨ Physician Sample wrongly printed with price.

Minor Deviation:

When the deviation does not affect any quality attribute,  critical process parameter, or anvequipment or instrument critical for process or control.

Examples of Minor Deviation:

⇨ Raw Material is received in a damaged container.

⇨ Manometer readings in the sampling booth are crossed the action limits.

Process flow Diagram for Deviation Management:

⇨ Deviation Initiator

⇨ Description of Discropancy

⇨ Formation of Investigation team & Investigation of Discrepancy

⇨ Root Cause Analysis

⇨ Proposed Corrective/Preventive Action

⇨ Proposal agreed by QA

⇨ Action taken by relevant Department

⇨ Close out comment of QA

⇨ Approval of Head of QA

⇨ Follow up/ Verification

⇨ Action taken effectively

⇨ Deviation closed

Relative Standard Deviation (RSD)

Relative Standard Deviation is a measure of precision (not accuracy). RSD is sometimes called coefficient of variation and often is calculated as a percentage. RSD is used to determine if the standard deviation of a set of data is small or large when compared to the mean deviation.

Calculation of RSD:

RSD = (S/X) × 100

where, 

S = Standard Deviation

X = Mean Deviation

Incident

Incident is any event that can affect the product or noy but that is againt the cGMP.

Change Control

Change control is the system that manages changes that may affect product quality or the reproducibility of the process.

Change control is a written procedure that describes the action to be taken if a change is proposed to facilities, materials, equipment, and/or processes used in the fabrication, packaging, and testing of drugs that may affect the operation of the quality or support system.

Types of Change Control:

⇨ Planned Change

⇨ Unplanned Change (Deviation system)

Identifying type of Change:

⇨ Temporary Change

⇨ Permanent Change

Level of Change Control:

⇨ Minor Change

⇨ Moderate Change

⇨ Major Change

Unplanned change:

Unplanned change is a change that occurs unexpectedly on an individual batch or process.

Out of Specification (OOT)

Out of Specification means an examination, measurement or test result that does not comply with pre-established criteria or specification. OOS indicates that the specification of the product wil be outside the upper or lower limit. OOS is related to non-conpliance with specification. OOS means the batch is failed to meet the specification. OOS needs correction.

Out of Trend (OOT)

Out of Trend is a result that does not follow the expected trend either in comparison with other batches or with respect to previous results collected during a stability study.

When a result exceeds the 80% of the specification limit, that result will be treated as Out of Trend. OOT needs prevention but not correction. OOT is related to within specification but having significant variability among the particular test parameter's data.

Difference between OOS and OOT

Please follow the link to learn about OOS vs OOT: OOS vs OOT

User Requirement Specification (URS)

The user requirement specification or user requirement document (URD) is a document usually provides a high level description of the user's expectation of the project scope, with emphasis on product parameters and process performance parameters.

Factory Acceptance Test (FAT)

A FAT is usually performed at the vendor prior to shipping to a client. The vendor tests the system in accordance with the clients approved test plans and specifications to show that system is at a point to be installed and tested on site. It is an essential aspect of the whole system lifecycle and should be performed by experienced personnel. Time spent doing a proper FAT will lead to fewer problems when the equipment is installed on client's site.

Site Acceptance Test (SAT)

SAT is a Site Acceptance Test. The system is tested in accordance to client approved test plans and specifications show the system is installed properly and interfaces with other systems and peripherals in its working environment.

AUDIT

Audit means systematic, independent and documented process for obtaining audit eviidence and evaluating it objectively to determine the extent to which audit criteria are filulfilled.

CAPA

CAPA means Corrective and Preventing Action.

Corrective action: Any action to be taken when the results of monitoring at the critical control point (CCP) indicate a loss of control. Corrective action is taken out on the product/process, system to minimize immediate defects or non-conformaces. (Contamination action)

Preventive Action: Action to minimize the cause of a potential non-conformity or other desirable potential situation. Preventive action is taken out on the system/process product to minimize potential defects or non-conformances recurring. (Permanent action)

Customer Complaint

A consumer complaint or customer complaint is an expression of dissatisfaction on a consumer's behalf to a responsible party. It can be described in a positive sense as a report from a consumer providing documentation about a problem with a product or service. In fact, some modern business consultants urge businesses to view customer complaints as a gift.

Type of Customer Complaint:

Basically it is three types:

1) Quality Complaints

2) Adverse Reaction Complaints

3) Other medical related Complaints

Product Recall

A product recall is a request tov return a marketed product for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be violation of the laws.

Root Cause

Root cause is the fundamental breakdown or failure of a process which, when resolved, prevents a recurrence of a problem.

Root Cause Analysis (RCA)

Root Cause Analysis is a method that is used to address a problem or non-conformance,  in order to set to the "Root Cause" of the problem. It is used so we can correct or eliminate the cause and prevent the problem from recurring. It is a systematic approach to get to the true root cause of our process problems.

Clean Room

Clean room is a room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room and in which other relevant parameters such as temperature, humidity and pressure are controlled as necessary.

Classification of Clean Room

According to European Economic Community Guidelines, Clean room has three types:

1) Grade A & B corresponds with Class 100

2) Grade C corresponds with class 10,000

3) Grade D corresponds with class 1,00000

Class 100 Clean room: Class 100 clean room is defined as a room in which the particle count in the air is not more than 100 per cubic foot of 0.5 micro meter and larger in size.

Class 10000 Clean Room: Class 10000 clean room is defined as a room in which the particle count in the air is not more than 10000 per cubic foot of 0.5 micro meter and larger in size.

Class 100000 Clean Room: Class 100000 clean room is defined as a room in which the particle count in the air is not more than 100000 per cubic foot of 0.5 micro meter and larger in size.

HEPA Filter (High Efficiency Particulate Air)

HEPA filters are essential to correct performance of a clean room. HEPA filters are made of compressed and bonded micro-fiberglass or Teflon corrugated to produce a high surface area in a small area panel of filter medium. Filters with a minimum efficiency of 99.97% for 0.3 micron particle size determined by test. The test can be by the mono-dispersed Dioctyl Phthalate method (DOP) or other equally sensitive method. When operated at design velocity, larger and smaller particles are captured at higher efficiencies.

HEPA filters exhibits:

⇨ A high flow rate

⇨ High particulate holding capacity

⇨ Low-pressure drop across the filter

ULPA (Ultra Low Penetration Air)

A ULPA can remove from the air at least 99.999% of dust,  pollen, mold, bacteria and any airbone particle with a size of 120 nanometers (0.12 micron) or larger.

SULPA (Super Ultra Low Penetration Air)

SULPA filters are available where maximum cleanliness is required. These filters have an efficiency of 99.9999% on the same basis as ULPA filters.

N.B: The low penetration expected from ULPA and SULPA filters is such that they must be totally free of even the smallest leak.

HVAC (Heating, Ventilation and Air-Conditioning)

HVAC is a system used for temperature and humidity control within a manufacturing environment. It includes air handling units, air distribution network, air-cooling and heating systems, air filtration, equipment control systems and monitoring and alarm device.

The Parameters of HVAC System:

⇨ Temperature

⇨ Relative Humidity

⇨ Air Class

⇨ Pressure Gradient

⇨ Air Quality

⇨ Sound level

SOP (Standard Operating Procedure)

An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material.

Purpose of SOP:

⇨ Serve as framework for organizational policy-provide direction and structure.

⇨ Written documentation of best practice.

⇨ Tells what, how, when, why, and who.

⇨ Provide foundatipn for Job description, Employee training, Corrective action and discipline and performance review.

Master Formula

Master Formula or Master Formula Record (MFR) is a document that includes all of the details about a Pharmaceutical product. The MFR contains all information about the manufacturing process of the products.

BMR (Batch Manufacturing Record)

A Batch Manufacturing Record in Pharmaceutical industry is information relating to the product and batch. It is a document that is intended to give a full and authoritative record of the manufacturing history of each batch of dvery product.

BPR (Batch Packaging Record)

Batch Packaging Record is a document that details the packaging process for a specific batch of a product. It ensure that the finished products meets safety and quality requirements.

The BPR acts as a checklist to ensure that the finished products meets specifications and safety requirements. It also helps to ensure that all products meet GMP.

Dossier

Pharmaceutical dossier is a set of documents which includes multi-disciplinary information regarding the safety and efficacy of the product.

The Pharmaceutica dossier includes:

⇨ The Company information in which that product was manufactured

⇨ The Master formula of the Product

⇨ The Manufacturing procedure and the equipments list used in the production

⇨ The Stability data

⇨ Priclinical and Clinical Data

⇨ Specifications used in testing the final product

⇨ Other documents

CTD (Common Technical Document)

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of application regarding new drugs intended to be submitted in regional regulatory authorities in participating countries.

Modules of CTD

The common Technical Document is divided into five modules:

1) Administrating and Prescribing Information

2) Overview and Summary of modules 3 to 5.

3) Quality (Pharmaceutical Documentation)

4) Preclinical (Pharmacology/Toxicology)

5) Clinical – efficacy (Clinical Trials)

ACTD

The ASEAN Common Technical Dossier is a guideline of the agreed upon common format for the preparation of a well-structured CTD applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.

Document

A document is a written, drawn, presented or recorded representation of thoughts. Documents can be stored as paper or digitally. It can be changed and revised as needed.

Documents are required for one or more of the following reasons:

⇨ Keep track of activities

⇨ Create legal documents

⇨ Provide a historical record

⇨ Provide information

⇨ Comply with regulations

Record

Records are historical files that provide proof of existence. They are used to prove a state of existence of the business. Records are not editable and cannot be recreated. In short it is a historical document. GMP record should have following characteristics –

⇨ Permanent

⇨ Legible

⇨ Accurate

⇨ Prompt

⇨ Clear

⇨ Consistent

⇨ Complete

⇨ Direct

⇨ Truthful

Documentation

Documentation is a set of documents that provides official information oS

 evidence or that serves as a record.

Controlled Documents

The document that have limited and specific distributions and are marked with red stamped phrase "Controlled" are termed as Controlled documents. It is the distribution that is being controlled. Examples of controlled documents are Quality Manual, Master Procedures, Standard Operating Procedures, Master Formulations and RM/PM Specifications etc.

Data

Data is a set of values of qualitative or quantitative variables. Facts and Statistics collected together for reference or analysis.

Data should be-

A – Attributable to the person generating the data.

L – Legible and Permanent

C – Contemporaneous

O – Original Record

A – Accurate

IPC (In-process Control)

The IPC is the checks performed during production in order to monitor and if necessary, to adjust the process to ensure that the product conforms to its specifications.

The In-process control is the checks made during the course of manufacture which aims to ensure that product will comply with specifications. Thus is build into the product. The objectives of in-process control are both quality control and process control.

IPC Checks during Dispensing

IPC Checks during Granulation

IPC Checks during Tableting

IPC Checks during Coating

IPC Checks during Capsule filling

IPC Checks during PFS Filling & Sealing

IPC Checks during Oral Liquid filling & Sealing

IPC Checks during Injectable Product filling & Sealing

IPC Checks during Aerosol & Spray Manufacturing

IPC Checks during Primary Packaging

IPC Checks during Secondary Packaging

Line Clearance

Line Clearance is the removal of all previous materials, product and related documents from the process line before starting the next new product or new batch of the same product.

Line Clearance prior to Dispensing

Line Clearance prior to Cmpression

Line Clearance prior to Primary Packaging

Line Clearance prior to Secondary Packaging

Pharmaceutical Guidelines

Please visit the following link for learning about Pharmaceutical guideline: Pharmaceutical Guidelines